Department of Biostatistics

Self-Study

January, 2003

Table of Contents

Summary

1. Mission 2. Historical context 3. Department Environment and Resources

3.1. Demographics 3.2. Tenure-track faculty development 3.3. Financial resources 3.4. Space 3.5. Governance 3.6. Intellectual environment 3.7. Key partnerships 3.8. Library 3.9. Statistical computing 3.10. Issues

4. Academic Programs in Biostatistics 4.1. PhD program 4.2. ScM program 4.3. MHS programs 4.4. Issues

5. Statistical education for Public Health Professionals and Scientists 5.1. Response to 1995 review 5.2. Introductory sequence for laboratory scientists 5.3. Distance education courses 5.4. Educational research 5.5. Service on student committees 5.6. MHS in bioinformatics 5.7. Issues/future directions

6. Research 6.1. Publications 6.2. Biostatistics grants 6.3. Faculty awards 6.4. Future research directions

7. Consulting Center 8. Shorter-term Action Items

1

Summary

The Department of Biostatistics was a founding department of the School of Public Health in 1917. It was the first department of statistical science in the US and has remained one of the world’s preeminent centers for biostatistical research, teaching and applications for 85 years.

The department has achieved success by following a few operating principles:

- Be an intellectual center for biostatistics research. - Define biostatistics broadly, from foundations to methods to applications. - Recruit talented younger faculty and give them support and freedom to achieve

their full potential. - Provide the highest possible quality statistical education to public health

professionals and scientists. - Keep the department size small enough that faculty can operate as a committee

of the whole and teach PhD students using an apprenticeship model.

Since the last review in 1995, the department has continued in this tradition and accomplished many important goals, including the following:

- Recruited 8 outstanding tenure-track faculty, including three who have been promoted to associate professor since arriving as new PhDs

- Re-designed statistical education for public health professionals and

scientists. We revised our introductory sequences into 4 levels: 611-614; 621-624; 651-654, and a new sequence 615-16 for laboratory scientists. We have also added advanced methods courses for PhD students in the social sciences, epidemiology, and genetics.

- Strengthened statistical research in molecular and population genetics.

The department now includes five tenure-track faculty whose statistical research focuses on genetics. With Epidemiology, we have created a five-course sequence on statistical genetics, one of the most comprehensive in the nation. In 2003-4, we are initiating a new MHS program in bioinformatics in collaboration with colleagues in the Schools of Public Health and Medicine.

- Strengthened the department’s infrastructure that supports faculty research

and student learning. The department is fortunate to have one of the University’s best administrative staffs. It now has a more competitive computing environment, including three full-time computer scientists, two as support staff for faculty. The endowment has increased from $0.8 to 4.5 million, providing some core funding for new hires and other initiatives. There is a monthly Biostatistics Grand Rounds that promotes interchanges among quantitatively-oriented faculty across the Medical Institutions. We have sustained and strengthened key

2

relationships with other departments – in particular, with Oncology Biostatistics, Epidemiology, and Molecular Microbiology and Immunology.

- Established the Hopkins Biostatistics Center to organize professional practice

beyond the scope of our usual collaborations with faculty colleagues. Each year, the Center provides fee-for-service consultation to more than 150 clients from Johns Hopkins, government, and industry and free consultation to another 100 who visit our walk-in clinic.

At our last annual retreat, faculty, students, staff, and key alumni prioritized opportunities to further strengthen Biostatistics and the School. The leading ones are:

- Enhance our research impact with coordinated efforts and investment in infrastructure for:

o biostatistics for genetics including bioinformatics o surveillance/public health informatics o clinical and community trials o foundations of inference

- Strengthen our computer science expertise as it is a key resource for our

successful research.

- Recruit five tenure-track faculty, mostly new PhDs, over the next five years to maintain our size in the range of 15-20 tenured and tenure-track faculty to meet the ever-growing demands for statistical research and education, and to introduce new ideas and methods to the department and school.

- Strengthen the PhD program by competing more effectively for the best

students, diversifying the student body, and setting high expectations for students to achieve their full potential, particularly five to ten years after graduation.

- Further improve the teaching of biostatistics for public health

professionals and scientists by o modularizing course materials with goals of continual improvement

and use in a variety of settings; o introducing innovative learning opportunities in the introductory

courses using web-based and other active learning methods; o diversifying and enriching biostatistics courses beyond the

introductory level; o offering short courses for specialized audiences; o successfully launching the new MHS in bioinformatics.

- Enhance our use of information technologies by improving faculty,

student, and staff skills and by creating improved research infrastructure

3

including databases and websites of international significance and additional faculty and staff with web and computing expertise.

1. Mission: The goal of the Department of Biostatistics, achieved through education, research, and professional practice, is to develop and apply effective statistical reasoning and methods for public health and biomedical research and ultimately, to advance the public's health.

2. Historical Context: A self-study of Hopkins Biostatistics must necessarily start with a brief review of its traditions and their continuing influence. Here, we focus on the history over the first half-century, when our traditions were firmly established.

Ours is the first academic department of statistical science in the US. Hopkins’s Biostatistics faculty have made seminal contributions to statistics and to the public’s health for 85 years. The first chair, Raymond Pearl, was a population biologist/ statistician, a student of Karl Pearson who was the first professor of statistics at University College, London and founding editor of Biometrika. Pearl published more than 700 hundred articles and 20 books in his career. He was the first person to show that moderate drinking prolongs life while smoking is associated with premature death (Science, 1939). Pearl was founding editor of the journals Human Biology and Quarterly Review of Biology; was an early advocate of birth control when that position was not socially acceptable, and he was a friend and weekly dinner partner of Baltimore's famous reporter and social critic, H. L. Mencken.

Lowell Reed became the department's second chair in 1926. He discovered the ED-50, a tool for toxicology, and the Reed-Frost epidemic model with epidemiologist Wade Hampton Frost, chair of Epidemiology. Lowell Reed was also an outstanding teacher, outshone in this arena only by his colleague Margaret Merrell. Lowell Reed also served as Dean of the School of Public Health from 1937 to 1946, and President of the University from 1953-1956.

William Cochran was professor and chair from 1948-1958 and widely considered to be among the most influential of American statisticians. He is the father of the modern approach to the analysis of data from observational studies. He authored several landmark books, including Experimental Designs (with Gertrude Cox), Sampling Techniques, Contributions to Statistics, and Planning and Analysis of Observational Studies. He developed regression and matching methods to control for confounding and investigated limitations inherent in observational research. In addition to being a world-famous statistician, Professor Cochran was also a leading public health figure, co-authoring the 1964 Surgeon General's report that identified tobacco as a cause of lung cancer.

Paul Meier was assistant professor in the Department from 1952 to 1957 when he co-authored with E.L Kaplan, their seminal paper "Nonparametric Estimation from Incomplete Observations," which appeared in the Journal of the American Statistical

4

Association in 1958. This paper introduced the Kaplan-Meier curve, one of the most influential methods in biomedical research and still one of the most cited.

Two faculty, Jerome Cornfield, fourth chair, and David Duncan played an important role in the development of logistic regression. Cornfield became interested in case-control studies through his work on smoking and lung cancer and proved that these studies can be used to estimate the risk of disease as a function of smoking status so long as the rate of disease in the population is known. His key finding that the odds ratio can be estimated either prospectively or retrospectively forms a basis for much of the modern era’s epidemiologic research.

During the 1950s, Professor Cornfield became deeply involved in the debate over the relationship between smoking and lung cancer. Against strong opposition from R.A. Fisher and Joseph Berkson (a 1928 graduate of the Department), Professor Cornfield, along with Doll and Hill, argued that the association was causal. He and co-authors Haenszel, Lilienfeld, and Wynder (among others) prevailed with arguments put forth in their seminal 1959 paper in the Journal of the National Cancer Institute. These activities initiated the department’s commitment to engaging in important and sometimes controversial public health issues.

Professor Cornfield became an active proponent of the likelihood principle -- that statistical evidence is summarized by the likelihood function -- and of Bayesian inference. His work on the foundations of biostatistical reasoning continues to the present day. Richard Royall’s book entitled Statistical Evidence: A Likelihood Paradigm is a mainstay of the likelihood movement and exerts a strong influence on our PhD program. Hopkins is also a leader in Bayesian biostatistics, with current faculty working on novel methods and applications.

David Duncan joined Hopkins Biostatistics in 1960. His early work focused on regression analysis, a topic to which he made two important contributions: First, he was an early advocate of what has become known as the Kalman filter, a method for dynamic estimation of the regression equation important to time series problems. Second, he and co-author Strother Walker discovered logistic regression analysis as early as 1967. It is unclear who was the first advocate of using logistic rather than linear regression for binary responses but Professor Duncan was certainly one of the first, building on work by Cornfield.

Even a brief history must emphasize the department’s consistent commitment to statistical education, particularly for public health professionals and scientists. Lowell Reed was an outstanding teacher of introductory courses, but perhaps his most important contribution in this area was to recruit Professor Margaret Merrell to the faculty in 1925. For the next 30 years, she was one of the world’s preeminent statistical educators. Dr. Merrell’s clarity and love of students was equaled by her protégé, Professor Helen Abbey, student and then professor in the department for over 50 years and one of the School’s most beloved faculty members. Professor Abbey instructed over 4,000 students in Biostatistics and was an advisor and thesis reader to more than

5

700 doctoral candidates. Among her students were ministers of health, directors of hospitals, university professors and health experts throughout industry and government. She taught two Lasker Award winners, Dr. Victor McKusick, Professor of Medical Genetics at Johns Hopkins University, and Dr. Alfred Sommer, Dean of the School of Public Health.

The department’s history over its first half-century manifested itself in our more recent past through the distinguished service of Allyn Kimball, Alan Ross, and Charles Rohde, our last three chairs. Its influence continues today. Our research is still characterized by a commitment to statistical science, its foundations and methods, as well as the application of statistical science to the solution of public health and biomedical problems. As indicated in the figure below, research on foundations, methods, and applications is mutually supportive. To be excellent, biostatistical research must be built on a foundation of first-rate public health and biomedical research, like that at Johns Hopkins.

Foundations Methodology Applications

Public Health and Biomedical Research

Research on foundations has as its goal the development of better strategies, or ways of reasoning, for empirical research. William Cochran demonstrated how observational studies can be used to draw inferences about the causal effect of a treatment on a health outcome. Jerry Cornfield showed how case-control studies can be used to draw valid inferences about parameters in prospective models. Richard Royall has led a transition in statistical reasoning toward likelihood methods, which quantify scientific evidence. Charles Rohde, Kung-Yee Liang, Steve Goodman, Tom Louis, Constantine Frangakis, and others continue this tradition.

Research on statistical methodology has as its goal the creation of new tools for inferences. To illustrate, Ron Brookmeyer and Mitch Gail developed the methodology used to monitor and project the size of the US AIDS epidemic; Kung-Yee Liang, Mei-Cheng Wang, Tom Louis, Karen Bandeen-Roche and Scott Zeger developed methods for regression analysis with correlated responses. Daniel Scharfstein and Constantine Frangakis have developed techniques for assessing the possible impact of missing data in clinical trials and observational studies. Kung-Yee Liang, Karl Broman, Rafael Irizarry, Elizabeth Garrett and Giovanni Parmigiani are developing new quantitative methods for genetics. Ingo Ruczinski has developed novel regression methods to predict how proteins will fold.

To accomplish societal goals, Biostatistics and biostatisticians must research important substantive questions as well. For example, Francesca Dominici, Aidan McDermott, Frank Curriero, and colleagues have used multiple national databases to determine the effects of air pollution on mortality across the 90 largest American cities. Marie Diener-

6

West, Jim Tonascia, Steve Piantadosi, Steve Goodman and others have led or collaborated in clinical trials of new therapeutic treatments. Karen Bandeen-Roche and Elizabeth Garrett collaborate with gerontologists to determine the causes and ultimately, to postpone the onset of disability in older adults. The Biostatistics Center faculty, including Richard Thompson, Elizabeth Johnson and Sarah Barry, serve more than 150 biomedical clients each year.

The historical commitment to education also continues, as is detailed below. Marie Diener-West is currently director of statistical education for public health professionals and scientists. She leads the planning and implementation of the department’s introductory courses that now comprise four distinct sequences that meet the disparate needs of the school’s students. With Dr. Diener-West, John McGready leads our growing distance education program.

3. Departmental Environment and Resources: This section summarizes the current state of the department with respect to core resources as well as trends since the last review. The final Section 3.10 discusses issues for the next five years that have been identified by the faculty.

3.1. Demographics: The number of faculty, students and staff for each of the last six years is presented in Table 3.1. There has been a growth in total tenure-track faculty from a low of 12 to the current 16. In addition, the department now includes 3 scientists, 3 research associates, and an instructor. The doctoral student numbers have also grown to meet increasing demand for PhD biostatisticians in academia, government, and industry. There has been a decrease in the number of master’s students, as competing universities offer tuition-free master’s programs. The staff size has remained nearly constant despite the growth in faculty and students.

3.2. Tenure-track Faculty Development: Tenure-track faculty time-in-rank is summarized in Table 3.2 for persons hired since1981. Over this period, the department has hired 19 tenure-track faculty; 14 of them remain members of the department today. Since the last review in 1995, we have hired 9 tenure-track faculty: 1 professor, and 8 assistant professors. All but one of these tenure-track recruitments remain at Johns Hopkins.

We have experienced an unanticipated reduction in availability of key faculty in the last year with Richard Royall’s retirement, Kung-Yee Liang’s three-year leave of absence to serve as Vice President of the Taiwan National Health Research Institute, and Constantine Frangakis’s fifteen-month leave of absence to serve in the Greek navy.

3.3. Financial Resources: Table 3.3 presents a summary of the sources of revenue to the department and how support has grown over the last 6 years. The total operating budget has increased from $3.6M to $4.3M, a moderate increase in real terms. This reflects the small growth of the faculty and stable mix of activities. After a banner year in 1998, total grant dollars for Biostatistics principal investigators has been roughly constant. Two new sources of revenue are from Biostatistics Computing Services and

7

the Johns Hopkins Biostatistics Center. As service centers, these receipts are directly offset by expenditures to provide consulting services and computer hardware, software and maintenance, respectively.

Finally, Table 3.3 shows the growth in the value of the endowment from $767K to $4,500K. This increase resulted from large gifts by Helen Abbey, Frank Hurley and Catharine Dorrier, and from consulting revenues to the department and center. In summary, the financial resources have increased modestly over the period since the last review, sufficient to support the hiring of junior faculty.

Table 3.1. Number of faculty, students and staff for each of the last 6 years.

FY98 FY99 FY00 FY01 FY02 FY03 Faculty Full Professor 8 8 8 8 8 9 Associate Professor 3 3 2 1 1 3 Assistant Professor 1 3 6 5 7 4 Total tenure-track 12 14 16 14 16 16 Instructor 1 Research Associate 2 3 4 3 3 3 Assistant Scientist 1 2 2 4 3 3 Total Non-tenure-track 3 5 6 7 6 7 Total Faculty 15 19 22 21 22 23 Staff 4 5 6 6 6 7 Biostat students PhD 27 28 26 29 30 37 Master’s 13 10 8 8 7 6 MHS 1 1 1 2 1 0 ScM 12 9 7 6 6 Total 40 38 34 37 37 43 Courses 41 49 55 54 63 59

Enrollments 2018 2382 2552 2842 2777

Data not yet

available

8

Table 3.2. Time-in-rank for tenure-track faculty hired since 1981.

Year

Name

Rank at

Recruitment

Years in

Rank

Promoted To

Years in

Rank

Current

Rank

Years in Current

Rank

1981 Ron Brookmeyer Asst Prof 4 Assoc Prof 5 Prof 12

C. Hendricks Brown Asst Prof 5 Assoc Prof 4 Left university

Steven Self Asst Prof 3 N/a n/a Left university

1982 Kung-Yee Liang Asst Prof 4 Assoc Prof 5 Prof 11

Scott Zeger Asst Prof 4 Assoc Prof 5 Prof 11

1985 Mei-Cheng Wang Asst Prof 6 Assoc Prof 7 Prof 4

1987 Subhash Lele Asst Prof 6 Assoc Prof 6 Left university

1990 Karen Bandeen-Roche Asst Prof 6 Assoc Prof 6 Prof <1

Marie Diener-West Asst Prof 4 Assoc Prof 6 Prof 2

Leonardo Epstein Asst Prof 5 Left university

1997 Daniel Scharfstein Asst Prof 5 Assoc Prof Assoc Prof <1

1998 Rafael Irizarry Asst Prof Asst Prof 4

Colin McCulloch Asst Prof 2 Left university

1999 Karl Broman Asst Prof 3 Assoc Prof Assoc Prof <1

Francesca Dominici Asst Prof 3 Assoc Prof Assoc Prof <1

Constantine Frangakis Asst Prof Asst Prof 3

2001 Brian Caffo Asst Prof Asst Prof 1

Ingo Ruczinski Asst Prof Asst Prof 1

2002 Thomas Louis Prof Prof <1

9

Table 3.3: Source of Department of Biostatistics revenues ($1,000).

Source

FY

1998

FY

1999

FY

2000

FY

2001

FY

2002

Projected FY

2003 General Funds (GF)

TAM 945 1,056 975 941 1,080 1,233 IDC 241 244 372 422 551 544 Total GF 1,186 1,300 1,347 1,363 1,631 1,777

Sponsored Projects*

1,589 (11)

1,320 (12)

1,105 (9)

1,278 (7)

1,212 (10)

1,248 (11)

Outside salary support **

878

806

773

936

1,062

1,168

Computer Services (BCSS)

100

127

141

145

Consulting Center

35

145

237

438

245

325

Total Operating Budget

3,688

3,571

3,562

4,142

4,291

4,663

Endowment Market Value

767

870

1,607

2,333

3,870

4,500

* Biostatistics PI, Direct Costs only (number of projects); ** Non-Biostatistics PI, includes salary and fringe

3.4. Space: The Department of Biostatistics currently occupies 12,500 square feet located in the School of Public Health’s Wolfe Street building. This total represents approximately 2.5% of the Wolfe Street building and roughly 1.5% of the School’s total space. Included in this total are staff offices, a research library, a conference room, server room, and a copier/supply room. Each faculty member currently occupies an individual office of approximately 160 square feet. All full-time students are provided a small amount of space in one of seven shared offices; current occupancy ranges from 5 to 8 students per office, a density that is not competitive with other departments of biostatistics and not sustainable for the future. The School has assigned new, contiguous space to the department that will support the modest growth planned and is of very high quality.

3.5. Governance: The department operates as a committee of the whole to address most issues. Faculty meetings are held twice per month on Fridays from 12:00-1:30.

10

All faculty who regularly contribute to the departmental teaching and research programs are invited, regardless of department of primary appointment. Two student representatives are also regular attendees, except when agenda items preclude their participation. Agendas are posted on a website prior to the meeting; minutes are posted afterward at http://www.biostat.jhsph.edu/biostat/event/facmtgs.shtml. Twice per year, the faculty meeting includes all joint appointees and twice per year, there is a “faculty/student forum.”

Roughly once per year, the department holds a 1 or 2-day retreat off-campus to address longer-term issues. Key external members of our community, including donors and adjunct faculty, are also invited. A list of retreats since the last self-study is provided below, with links to summaries of the main topics discussed.

September 21, 1996 (http://www.biostat.jhsph.edu/biostat/self_study/m092196.pdf)

December 13, 1997 (http://www.biostat.jhsph.edu/biostat/self_study/m121397.pdf)

February 27, 1999 (http://www.biostat.jhsph.edu/biostat/self_study/m022799.pdf)

October 28, 2000 (http://www.biostat.jhsph.edu/biostat/self_study/m102800.pdf)

September 21, 2001 (http://www.biostat.jhsph.edu/biostat/self_study/m092101.pdf)

3.6. Intellectual Environment:

Seminars: During the academic year, seminars are held weekly on Wednesdays from 3:45 – 5 PM to update students and faculty on the latest research of leading statisticians. Seminar speakers usually spend a day visiting the department, informally meeting and interacting with students and faculty to discuss topics of mutual interest. Seminar schedules for the current and previous academic years are located at http://www.biostat.jhsph.edu/biostat/event/seminar/seminars.shtml. Grand Rounds: The first seminar of each month is designated as Biostatistics Grand Rounds, which is dedicated to advancing the practice of biostatistics at the Johns Hopkins Medical Institutions. The goal of Grand Rounds is to illustrate successful collaborations between substantive and biostatistics researchers. Modeled after medical rounds, a substantive expert presents background material including the scientific question; a biostatistician then presents the statistical analysis used to address the question. Medical and statistical discussants provide critiques. Grand Rounds carry CME credit. The Grand Rounds website is located at http://www.biostat.jhsph.edu/biostat/event/grandrounds/grandrounds.shtml. Working Groups: Theme-oriented working groups are a mechanism by which faculty and students exchange knowledge and ideas in a particular research area. Working groups are informal and change over time. Currently, there are five groups:

11

o The Expressionists (http://astor.som.jhmi.edu/hex): dedicated to the informal development and dissemination of statistical methods for large-scale genomics experiments.

o The Longitudinal Working Group

http://www.biostat.jhsph.edu/biostat/research/longworkgroup.shtml): This group periodically invites statisticians to give an informal working seminar on issues related to the analysis of longitudinal data. The speakers also spend the day meeting with members of the group to discuss issues of mutual interest.

o The ROC (Randomization-Observation Continuum) Group: This group meets

periodically to discuss issues related to synthesizing and summarizing evidence based on the results of randomized and observational studies.

o The Environmental Biostatistics Working Group

(http://ihapss.biostat.jhsph.edu/~Ebwg): This group meets weekly to discuss and collaborate on research, provide a forum for student participation/mentorship, and develop proposals for extramural funding. The group works to enhance visibility and integration of related activities in Biostatistics, Epidemiology and Environmental Health.

o The Epidemiology and Biostatistics of Aging Research in Progress Group: This

group meets every two weeks to foster education and research related to aging and health. It provides students and faculty a forum to report their research, offer and receive research feedback, forge collaborations, and informally discuss quantitative methods and prominent publications. The group is affiliated with, but not limited to, the Johns Hopkins Training Program in the Epidemiology and Biostatistics of Aging.

Student Journal Club: This student-run, faculty-facilitated group meets three times per term to present and discuss statistical journal articles. The journal club’s goals are: 1) to read critically; 2) to present informally; 3) to become more familiar with seminal papers and current topics in statistics; and 4) to develop the habit of staying in touch with the literature. Further information is available at the journal club’s website: http://www.biostat.jhsph.edu/~weddings/academic/journalclub/info.html.

3.7. Key Partnerships: As listed in Table 3.4, Biostatistics faculty have established many important collaborations in research and education. These include five graduate training programs and 16 research centers or programs. Collaboration with scientists in every department of this school and most in Medicine underpin the faculty’s research across the spectrum from foundations to methods to applications. When we recruit new junior faculty members, the richness of these partnerships gives Hopkins a competitive advantage.

12

Of particular importance are collaborations with the biostatistics faculty in Oncology and with bioinformatics faculty in MMI who teach many courses, direct graduate students, and participate fully in the planning and conduct of biostatistics activities. Given the relatively small size of the primarily-appointed faculty, active joint appointees make it possible for our research and graduate programs to be world-class. A case in point is the initiative in bioinformatics that is jointly directed by Giovanni Parmigiani and Fernando Pineda, both joint appointees.

3.8. Library: As a supplement to the resources in the university libraries, the Department of Biostatistics maintains a library of more than 5,000 books and 20 academic journals. It has become outdated in recent years and requires a non-trivial investment in resources to update the collection and create an accurate, electronic catalog. The library must also add online library resources. Finally, the library is overcrowded and must be moved into a larger space.

Table 3.4. Key Partnerships in Programs or Centers for the Department of Biostatistics Programs Centers Bioinformatics Center for Adolescent Health Promotion and

Disease Prevention Drug Dependence Training Program Center for Clinical Trials Genetic Epidemiology Center for Research on Services for Severe Mental

Illness Graduate Training Program in Clinical Investigation Center for Prevention and Early Intervention

(funding pending) Graduate Training Program in Public Health Center for the Prevention of Youth Violence Robert Wood Johnson Clinical Scholars Program Center on Aging and Health Training Program in Psychiatric Epidemiology Dana Center for Preventive Ophthalmology Training Program in Biostatistics and Epidemiology of Aging

Hopkins Population Center

Malaria Research Institute NIEHS Center in Urban Environmental Health Oncology Biostatistics Older Americans Independence (Pepper) Center Risk Sciences and Public Policy Institute Roger C. Lipitz Center for Integrated Health Care Welch Center for Prevention, Epidemiology and

Clinical Research Women's Health and Aging Study

3.9. Statistical Computing: To succeed, a biostatistics department requires a competitive statistical computing environment. Increasingly, a department must also have computer science expertise to address informatics problems that arise with the increasingly large and complex data sources we analyze. We would also benefit from enhanced capacity to design and implement web interfaces to disseminate the data and statistical software we develop.

13

Our computing environment is overseen by the Biostatistics/informatics Information Technologies (BIT) Committee that is joint with MMI. See their website at http://biosun01.biostat.jhsph.edu/%7Eririzarr/BIT/ for resources created by this active group. The department currently runs two server clusters. The first is a SUN Enterprise server with eight processors and a total of 16 GB of RAM running Solaris 2.8. Each member (faculty/students/staff) of the department has an account on this server and is expected to keep all his/her important data on it. Files are backed up daily. This computer has an open port for secure shell protocol to connect remotely. Using Concurrent Versions System (CVS), members of our department can use the port to collaborate on statistical software developed and maintained by scientists around the world. One example is the Bioconductor Project to develop software for gene expression array data analysis that Rafael Irizarry participates in with colleagues at Berkeley, Harvard and other centers.

The second cluster has just been purchased jointly with MMI and comprises 8 Intel chips with a grid software system. It will be used to serve bioinformatics research and educational programs, particularly associated with the Malaria Institute.

The department also maintains a web server (http://www.biostat.jhsph.edu/). Each member of the department has the opportunity to post a personal webpage on this server. Many use this resource to make unpublished manuscripts and PowerPoint slides from talks available to the scientific community. We also use it to share internal information on webpages available for internal use only. A problem for the department is to improve the position of its pages in lists from commercial searching systems like Google. Each faculty and staff member has a desktop computer in his/her office. Students have two computers per office of 5-8 students. These computers are usually Intel PCs running either Red Hat Linux or Windows 2000. Windows users have the ability to connect to the server using either PCXware or Xseed. Linux users are provided a Windows installation on Vmware that enables them to work with documents that can be opened with tools available for Linux -- e.g., Microsoft office suite. The ability to work in UNIX and Windows systems from one platform remains a challenge. We currently have one master’s-level computer scientist, Jiong Yang, trained in Windows, Linux, and Solaris. A web programmer, Sherry He, has recently joined us to develop web-based data systems. MMI has one systems programmer who also supports our users of the Linux cluster.

3.10. Resource Issues – This section summarizes key issues related to departmental resources that faculty have identified as requiring attention over the next few years.

Diversification of biostatistics and future department growth – A continuing concern for the department is how to maintain its current “committee of the whole” environment of 15-20 faculty while keeping abreast of the diversifying field of

14

biostatistics. For example, in recent years, the department increased the number of persons working on statistical problems in genetics. But the total faculty size has not grown proportionately and so there are fewer individuals working on more traditional biostatistical problems. Bioinformatics is a second example where the department could add substantial numbers of faculty to meet the expanding opportunities. The issue is how to remain a leader in biostatistics as the field diversifies while maintaining research and education in “traditional” areas and preserving our intellectual environmental that contributes to the quality of research and to the graduate program.

Over the last 20 years, the department has not attempted to respond to all statistical opportunities but has been selective in choosing research areas where it can maximize its impact. For example, it has not competed for clinical trial or field study coordinating centers that require many faculty appointments, particularly in non-tenure track positions. Instead, Biostatistics faculty have led or participated in trials through the Center of Clinical Trials, where the necessary infrastructure has been successfully built. Choosing the “right size” for the department is a trade-off between maintaining the collegiality that comes with the current faculty size and responding to the opportunities in genetics, bioinformatics, surveillance/environmental statistics, clinical trials, and other areas, each of which could grow substantially over the next several years. It remains a delicate process to achieve selective excellence.

Informatics – The department’s information and computing needs are growing in both research and education. There is an explosion in the size and complexity of information we analyze. An emerging research area, “reproducible research,” as a recent seminar speaker labeled it, aims to develop methods and software to ensure the validity of inferences drawn from large, complex studies. There is increasing need for computer science expertise on our research teams. The contributions of computer scientists are likely to be software systems or websites, rather than more traditional peer-reviewed papers. There is also demand for staff programmers to code software for efficient implementation and web-based dissemination of the methods developed. Educational programs are raising similar demands. The issue here is how to recruit and reward such faculty within the Department of Biostatistics. A related issue is how to maximize the impact of our department’s research by disseminating its papers, software, and databases via the web. One strategy is to continually upgrade faculty, student, and staff expertise in the use of information systems.

Faculty titles – Since the last review, the School has created an expanded set of non-tenure track faculty titles, including non-tenure track professorial faculty. Biostatistics has decided not to use the professorial title except for those faculty on the tenure track. The expansion of faculty titles has raised concerns among our scientist faculty, some of whom are comparable to non-tenure track research assistant professors in other departments. Issues include how to ensure that scientists are rewarded consistently with their research accomplishments and how to avoid the appearance or reality of a

15

faculty hierarchy. Furthermore, differences in how titles are used among departments has the potential to create faculty concerns that need to be monitored.

4. Academic Programs in Biostatistics

4.1. PhD program Overview: The Johns Hopkins Department of Biostatistics PhD program prepares persons who have demonstrated excellence in mathematics and the natural or social sciences to become research biostatisticians in academia, industry, or government. PhD graduates:

• Conduct and publish original research on the theory and methodology of biostatistics;

• Apply innovative theory and methods to the solution of public health problems; • Serve as expert biostatisticians on collaborative teams of investigators

addressing public health questions; • Teach biostatistics effectively to health professionals and scientists as well as to

graduate students in biostatistics.

The PhD program provides training in the theory of probability and statistics and in biostatistical methodology. The program is unique in its emphasis on the foundations of statistical reasoning and in requiring its graduates to complete rigorous training in real analysis-based probability and statistics, equivalent to what is provided in most departments of mathematical statistics. The core curriculum consists of four components:

• A two-year sequence on biostatistical methodology (140.651-654, 140.751-754); • A two-year sequence on the foundations and theory of statistical science

(140.671-674, 140.771-774); • Real analysis and advanced probability (110.405-406 or 550.620-621); • Principles of Epidemiology (340.601) plus other non-Biostatistics courses totaling

a minimum of 12 credits.

The department is committed to providing every opportunity for its students to successfully complete their academic program. Since the 1993-94 academic year, 62% of students who initially enrolled in the PhD program successfully completed it. To support students in progressing toward the degree and to further their educational experience, the department gives a comprehensive written examination at the end of the first year and a departmental oral examination at the end of the second year. To ensure uniformity in the examination process, the second-year departmental exam committee is comprised of the same four faculty members for all students. The University preliminary oral examination, where a critical literature review is presented and discussed, is typically taken at the beginning of the third year. Each student now has a thesis research committee that comprises two members from the department and

16

two from outside. This committee monitors progress and meets with the student annually to provide feedback. Final public orals have recently been changed to begin with a public lecture, followed by private questioning with the examination committee.

Table 4.1. Thesis Titles of Recent Biostatistics PhD Graduates, Academic Years

1997-1998 through 2002-2003 Lname Fname Yr Grad Advisor Thesis Title

Blades Natalie 02-03 Parmigiani Statistical Methods for Serial Analysis of Gene Expression

Boyd Felicity 02-03 Diener-West Methods of Learning in Statistical Education: Design and Analysis of a Randomized Trial

Fan Ming-Yu 01-02 Rohde Measures of Relative Importance and Related Statistics Hsu Fang-Chi 01-02 Liang Multipoint Linkage Disequilibrium Mapping Approaches Based on the

Case-Parent Trio Design Huang Chiung-Yu 01-02 Wang Modeling and Estimation for Recurrent Event Data with Dependent

Censoring Travison Thomas 01-02 Brookmeyer Global Effects Estimation for Multidimensional Outcomes Data Brown Clayton 00-01 Liang An Estimating Equations Approach to Random Effects Models and

Rate-of-Change Under Informative Dropout Huang Guan-Hua 00-01 Bandeen-Roche Analysis of Multiple Indicators Using Marginal Models and Latent

Class Regressions Hwang Wei-Ting 00-01 Brookmeyer The Analysis of Staged Panel Data under Heterogeneity Lu Shou-En 00-01 Wang Marginal Analysis and Cohort Case-Control Design for Clustered

Failure Time Data Rees Renée 00-01 Diener-West Estimating the Hazard Ratio in the Presence of Treatment Lag Xue Qian-Li 00-01 Bandeen-Roche Latent Variable Regression Analysis with Missing Covariates Blume Jeffrey 99-00 Royall On the Probability of Observing Misleading Evidence in Sequential

Trials Chiu Yen-Feng 99-00 Liang Multipoint Linkage Detection in the Presence of Heterogeneity

Garrett Elizabeth 99-00 Zeger Graphical Diagnostic Tools for Standard Latent Class and Latent Class Regression Model Assessment with an Application in Describing Depression and Validating Diagnostic Criteria for Depression

Kou Jingyee 99-00 Rohde A Predictive Spatial-Temporal Model for Boreal Forest Succession Miglioretti Diana 99-00 Zeger Template Mixture Models for Functional Brain Mapping Xu Jane 99-00 Zeger Surrogate Endpoints in the Analysis of Longitudinal Data Chen Yingqing 98-99 Wang Accelerated Hazards Model and Its Extensions Das Abhik 98-99 Lele Topics in Spatial Statistics Gray Sarah 9899 Brookmeyer Analysis of Multidimensional Longitudinal Data Guo Chuanfa 98-99 Royall Combining Information: A Likelihood Approach Huang Wenzheng 98-99 Royall Unbiased Generic Likelihood Wang Nae-Yuh 98-99 Liang On the Use of Extended Generalized Estimating Equations for

Regression Analysis under Non-Standard Situations Chen Min-Chi 97-98 Bandeen-Roche On Modeling and Inference for Multivariate Failure Time Data Rathouz Paul 97-98 Liang Nuisance Parameters, Measurement Error and the Efficient Use of

Auxiliary Data for Estimating Unobserved Occupational Exposures

17

Table 4.2. First jobs assumed by PhD graduates of the department Academic Years 1997-1998 through 2002-2003

Year Name Degree Position 2002-2003 Natalie Blades PhD Postdoctoral Associate Jackson Laboratory Felicity Boyd PhD Postdoctoral Fellow, Department of Biostatistics, Johns Hopkins University School of

Public Health 2001-2002 Ming-Yu Fan PhD Assistant Professor, Washington University School of Medicine Fang-Chi Hsu PhD Assistant Professor, Department of Public Health Sciences, Wake Forest University Chiung-Yu Huang PhD Assistant Professor, Division of Biostatistics, University of Minnesota Thomas Travison PhD Biostatistician, Wyeth Research 2000-2001 Clayton Brown PhD Assistant Professor, Department of Epidemiology & Preventive Medicine , University of

Maryland Guan-Hua Huang PhD Assistant Professor, Department of Preventive Medicine, University of Wisconsin-

Madison Wei-Ting Hwang PhD Assistant Professor, Department of Biostatistics and Epidemiology, University of

Pennsylvania Shou-En Lu PhD Assistant Professor, Division of Biostatistics, University of Medicine and Dentistry of

New Jersey Renée Rees PhD Biostatistician, Clinical Trials and Survey Corporation Qian-Li Xue PhD Assistant Scientist, Department of Epidemiology, Johns Hopkins University School of

Public Health 1999-2000 Jeffrey Blume PhD Assistant Professor, Center of Statistical Sciences, Brown University Yen-Feng Chiu PhD Assistant Investigator, Taiwan National Health Research Institutes Division of

Biostatistics and Bioinformatics Elizabeth Garrett PhD Assistant Professor, Department of Oncology , Johns Hopkins University School of

Medicine Jingyee Kou PhD Biostatistician, US Food and Drug Administration Diana Miglioretti PhD Biostatistician, Center for Health Studies, Group Health Cooperative of Puget Sound Jane Xu PhD Biostatistician, Novartis Pharmaceuticals 1998-1999 Yingqing Chen PhD Assistant Professor, Department of Biostatistics, University of California, Berkeley Abhik Das PhD Statistician, Research Triangle Institute Sarah Gray PhD Statistician, Genentech, Inc. Chuanfa Guo PhD Assistant Professor, Department of Epidemiology & Preventive Medicine, University of

Maryland Wenzheng Huang PhD Assistant Professor, Department of Biostatistics, Harvard University School of Public

Health Nae-Yuh Wang PhD Instructor, Department of Medicine, Johns Hopkins University School of Medicine 1997-1998 Min-Chi Chen PhD Assistant Professor, Department of Public Health, Chang Gung University College of

Medicine Paul Rathouz PhD Assistant Professor, Department of Health Studies, University of Chicago

Academia

Government

Industry

Total

Number 18 2 6 26 Percent 69% 8% 23% 100%

All PhD applicants (US and international) are ranked based upon their merits; top candidates are offered assistantships lasting five years and including full tuition, health insurance, and a living stipend starting at $18,000 per year. In exchange, students are required to apprentice with faculty as research and teaching assistants for up to 20 hours per week. Attendance at departmental seminars and Grand Rounds is required for all graduate students.

18

4.1.1. Overview of Graduates:

PhD Theses: As shown in Table 4.1, PhD graduates conduct research on a diverse set of problems. In recent years, there have been theses on neuro-imaging (Miglioretti), statistical genetics (Hsu, Chiu), statistical foundations (Fan, Travison, Blume, Rathouz) and environmental statistics (Kou) as well as statistical methodology. With few exceptions, PhD graduates publish their theses in leading statistical journals and continue to engage in statistical methodology and collaborative research relevant to public health and medical sciences (see Appendix 1: http://www.biostat.jhsph.edu/self_study/appendix1.pdf).

Jobs: The job market for the profession of biostatistics has been and continues to be favorable. As shown in Table 4.2, after receiving their PhD degrees, a majority of our graduates stay in academia, with primary appointments as biostatistics faculty at leading universities, including Harvard and the Universities of Chicago, Wisconsin, Minnesota, and California at Berkeley.

Time to complete degree. Figure 4.1 shows a Kaplan-Meier survival curve for the time from matriculation until graduation for PhD students in the department who started since 1993. The median time to complete the degree after entering our PhD program is five years. We believe that four to four and a half years is more reasonable, considering that students can start their thesis work at the beginning of the third year. But we recognize that the longer time to completion partly results from the important roles our students play as professional statisticians on research grants around the school and university. We discuss this further in Section 4.10 below.

Figure 4.1. Kaplan-Meier estimate of survival function for time from start to finish of PhD program for students beginning since 1993.

19

4.1.2. Core content: The core PhD curriculum has a simple structure comprising two two-year sequences in theory and methods in addition to coursework in advanced probability and epidemiology. The Curriculum Committee has developed a list of the specific topics it deems essential for mastery by our PhD students. Topics are organized by the courses in which they are covered in our core curriculum, years 1-2. Also included are key books that are recommended for the instructors and students (see Appendix 2: http://www.biostat.jhsph.edu/self_study/appendix2.pdf). These topic lists were developed during the past academic year and will be updated periodically, since the field of biostatistics is evolving rapidly. Curricular and other information for students is available in our web-based student handbook (http://www.ihapss.jhsph.edu/twiki/bin/view/Well/WebHome).

4.1.3. Training grants: The department offers NIH funded training programs in two areas:

- Biostatistics/Mental Health Psychiatry: http://www.biostat.jhsph.edu/biostat/research/grantliang2.shtml;

- Epidemiology and Biostatistics of Aging: http://www.biostat.jhsph.edu/biostat/research/grantaging.shtml.

The faculty have identified opportunities to compete for new training grants in environmental epidemiology, bioinformatics, and biostatistics for undergraduates. The bioinformatics grant will focus on postdoctoral students seeking an MHS in our new program.

4.1.4. Applications: As shown in Appendix 3 (http://www.biostat.jhsph.edu/self_study/appendix3.pdf), over the past five years, the number of applicants to the PhD program has more than doubled, from 51 to 133 per year. Roughly 10% of applicants are admitted with an offer of funding, half of whom, on average, choose Hopkins over other offers. In the field of biostatistics, highly-qualified students receive numerous offers with full funding, making an acceptance without funding equivalent to a rejection. The growth in applications has come almost entirely from foreign students, mainly Chinese. A concern for the future is the high degree of dependence on this single source of applicants.

4.1.5. Student Funding: Tables 4.3a and b show the moderate growth in full-time PhD student enrollment over the past three years, from 29 to 37. It also shows that while tuition and health insurance costs have risen, the portions covered by the department and grants have remained relatively constant. Stipend distribution has also remained constant during this period.

4.1.6. Student and Graduate Survey: To investigate the degree of satisfaction among students and graduates of our program, we undertook a web-based survey. The majority of the online survey was patterned after and drawn from the 2000 National Doctoral Program Survey (NDPS), conducted as an assessment of educational practices in doctoral programs in the US and Canada. We surveyed 54 persons with a 60% response

20

rate; the details of the survey are given in Appendix 4 (http://www.biostat.jhsph.edu/self_study/appendix4.pdf). This section briefly summarizes the main findings. Overall there was substantial satisfaction among both current students and graduates. All of the respondents indicated they were satisfied or very satisfied with the overall program and their advisors, with 90% indicating satisfaction or strong satisfaction with the program's courses and 94% indicating they would recommend the Biostatistics program to prospective students. However, the survey did identify some weaknesses in the program from the student/graduate perspectives. These include: insufficient advance information about the length of the program; mentoring for teaching assistants; courses/education regarding professional practice (for example, on how to be effective consultants); and career mentoring, particularly for those interested in industry. The graduate program committee will study these recent survey results in more detail and make recommendations about how to improve the program in light of this feedback.

4.2. ScM Program. The ScM program is intended for individuals who have demonstrated excellence at the undergraduate level in quantitative or biological sciences and a career as a professional statistician. Typically, ScM graduates assume positions in research or professional settings as scientific project coordinators and data analysts where they:

• Design research studies of human health and disease; • Design and implement data management systems; • Design and implement tabular and graphical displays of quantitative information; • Draw inferences from quantitative data.; • Use statistical reasoning and theory to deal effectively with non-standard

statistical problems; • Perform major statistical analyses to address public health or statistical research

questions; • Assist statistical researchers in the conduct of original, methodologic research.

The ScM program typically takes two years, with the first eighteen months spent in didactic coursework and the final six months spent working closely with a departmental faculty member in a master's thesis project. ScM students take the first year written qualifying exam with the PhD and MHS students. This program has had few candidates over the last decade because of the high cost relative to competing universities, which fully fund such programs. The faculty reviewed this trend at its last retreat and surveyed other university programs. Absent a source of funding for ScM students, we do not believe there is substantial chance to reverse this trend in the near future.

4.3. MHS Program: The MHS program is intended for individuals with prior professional experience or a professional degree (ie, PhD or MD) seeking a one-year intensive

21

course of study in biostatistical theory and methods. It is also open to students concurrently enrolled in a doctoral program at the Bloomberg School of Public Health. MHS graduates:

• Design research studies of human health and disease; • Design and implement data management systems; • Design and implement tabular and graphical displays of quantitative information; • Draw inferences from quantitative data; • Use statistical reasoning and theory to deal effectively with non-standard

statistical problems.

Table 4.3a. Support for Full-time PhD Students with Departmental Funding (in thousands of dollars)

FY00 FY01 FY02 Number of students ever enrolled in year 24 26 29 Tuition Department $355 76% $424 77% $572 80% Grants $113 24% $126 23% $145 20% Total $468 100% $551 100% $718 100% Health Insurance Department $13 61% $13 59% $17 57% Grants $8 39% $9 41% $12 43% Total $22 100% $23 100% $29 100% Stipend/Wages Department $32 8% $45 11% $61 12% Grants $352 92% $352 89% $429 88% Total $385 100% $398 100% $490 100% Total Support $876 $972 $1,218

22

Table 4.3b. Average Stipend/Wages for Funded PhD Students by year in Program during Fiscal Year 2001

Year Stipend 1 $15,000 2 $21,709 3 $23,822 4+ $21,365

(Not reflected in these tables is the increase in stipends required in FY03 in order to attract students to our program. The department currently guarantees incoming students $18,000 in stipend/wages during each of their five funded years.)

The MHS program involves one year of coursework (64 units) in biostatistics and other disciplines. Students are required to take the first year comprehensive written examination. Students must demonstrate competence in material covered by the Biostatistics courses 140.651-654, 671-674, and Principles of Epidemiology 340.601. A thesis is not required.

4.3.1. Concurrent School-Wide MHS Program in Biostatistics: The object of this program is to provide doctoral students in other departments with the opportunity to learn biostatistics concurrently with their doctoral program. Students must have been accepted into one of the doctoral programs in the School of Public Health. With the primary department's approval, the student may apply to the Master of Health Science program in Biostatistics. Students already in residence may also apply to the program. Specific details about sequencing of courses, etc., are arranged in conjunction with the doctoral program involved. Coursework in 140.651-654 and 140.671-674 is required. The curriculum is the same as that for regular MHS candidates in Biostatistics.

Upon completion of the required course work, the student will take the Biostatistics first year comprehensive written examination. Satisfactory performance on this examination and in the required coursework completes the MHS program in Biostatistics component of the concurrent program.

4.4. Issues for Graduate Programs in Biostatistics: This section identifies issues raised in the review of educational programs at the last retreat and in faculty meetings since.

Success of PhD graduates. The department seeks to instill in its students the importance of publication or equivalent productivity throughout their careers. Toward this end, we are encouraging students to adopt a “paper-style” thesis format, consisting of a chapter on introduction/literature review, a chapter on conclusions/discussion, and three middle chapters in the form of journal articles. In addition, organizing their work in this format will put students in better positions to compete for student awards (such as

23

those sponsored by ENAR and ASA) and for job interviews. In a similar vein, we encourage students to attend and present their work at scientific meetings, thus providing them with the opportunity to broaden their scope and vision through exposure to leading scientists in the field. Further recommendations will be developed from the analysis of the student/graduate survey described in Appendix 4 (http://www.biostat.jhsph.edu/self_study/appendix4.pdf).

Time-to-completion: We seek to reduce the typical time to completion of the PhD to four years. Toward this end, we have recently implemented a recommendation made by the PhD Curriculum Committee that a thesis committee be formed and meet regularly to monitor the progress of students’ thesis work. In some cases, one reason for slow progress is the large amount of consulting students undertake in the latter years of their program. Source of students in five years: Since the 1997-98 admissions cycle, almost 70% of our PhD applicants have been foreign; a majority of these are from China. During a recent visit to Hopkins, Professor George Tiao, a distinguished professor from the University of Chicago with strong contacts in China, pointed out that China’s rapid economic development has created a dramatic increase in jobs at home. Added to this is the recent growth and strengthening of Chinese graduate institutions. In the near future, both developments could have a profound impact on our student source. To counter this potential shift in applicants, it is imperative that we expand our efforts at recruiting students from the US and Europe as well as Asia.

Mentoring for concurrent MHS students: Feedback from students in the joint MHS programs suggests that they seek better integration into the department during their training. Starting with the 2003-4 academic year, Biostatistics will establish a mentoring system for students in the joint program. The department needs to determine what form this mentoring should take.

5. Statistical Education for Public Health Professionals and Scientists: For 85 years, the Department of Biostatistics has been committed to excellent statistical education of public health students. Over the last four years, the number of courses has increased from 41 to 65 and the number of enrollments from 2,018 to 2,842. This increase of roughly 50% represents a more rapid increase than the size of the tenure-track faculty, which has grown from 12 to 16. In addition to the four introductory statistics sequences, there are advanced and special topics courses, as detailed in Appendix 5 (http://www.biostat.jhsph.edu/self_study/appendix5.pdf).

The student feedback has nearly always expressed satisfaction at the quality of the learning opportunities, particularly in the introductory sequences. An analysis of the correlation between class size and quality (measured by the percentage of students who rate the course very good/excellent) shows that the quality remains high across the

24

range of class sizes. Routinely, over 80% of students rate the Biostatistics classes as very good or excellent.

Biostatistics faculty also work one-on-one with a large number of public health students in informal meetings and as members of examination and thesis committees. The faculty appreciate this opportunity to advance the public’s health by teaching future leaders.

In the 1995 review, the committee made several recommendations regarding our teaching of public health students. We begin this section with a discussion of how the department addressed each of these recommendations. We then discuss some of the major developments since the last review, including the new introductory sequence for laboratory scientists, the new bioinformatics MHS program, our new research program on educational methodology, and the continued importance of one-on-one interactions with students as evidenced by service on student committees. Finally, in Section 5.7, we raise pending issues that the faculty believe need further consideration. 5.1. Improvements in Response to the 1995 Review: In 1995, the Biostatistics Review Committee raised the following key issues regarding the teaching of biostatistics to non-departmental students:

- content of the introductory course series; - the need for statistical methods for graduate students in the behavioral and social

sciences; - the availability of appropriate statistical advice and faculty service on a non-

departmental doctoral candidate’s dissertation committee.

To address the first issue above, the Department of Biostatistics held a series of workshops with faculty, students, and graduates to better understand what knowledge and skills should be taught in our introductory courses. In 1997, a Biostatistics committee (Brookmeyer, Diener-West and Royall) issued a report, widely reviewed by faculty and student groups, that recommended changes to introductory statistical education. After incorporating feedback, two new introductory course sequences were created and initiated in 1998-1999. The Biostatistics 140.611-612 sequence was designed de novo for MPH and other degree candidates as a way of teaching biostatistics to those students who need to read scientific journals but do not plan to conduct their own data analyses. A new mid-level sequence, 140.621-4, was developed at a higher level than the old 140.601-4 sequence. Its goal is for students to learn data analysis skills using a modern statistical analysis package (now, Stata). Students conduct realistic analyses of several important data sets (Maryland costs for carotid endarterectomy, air pollution and mortality time series data from Philadelphia, sociodemographic and risk behavior data from a class survey, and child mortality data from a randomized field trial of vitamin A in Nepal).

These changes resulted in three introductory course sequences designed to meet different needs for different types of students and degree programs:

25

• Biostatistics 140.611-612 (3 units x 2 terms) – an introduction to statistical reasoning and methods intended to prepare students to read and understand the public health and biomedical literature (websites: http://www.biostat.jhsph.edu/~jmcgread/bio611/ and http://www.biostat.jhsph.edu/~jmcgread/bio612/ );

• Biostatistics 140.621-623,624 (4 units x 4 terms) – intended to prepare students at an elementary mathematics level to conduct or participate in teams that design, implement, and analyze data from research or professional practice programs (websites: http://www.biostat.jhsph.edu/courses/bio621/ , http://www.biostat.jhsph.edu/courses/bio622/ , http://www.biostat.jhsph.edu/courses/bio623/ , and http://www.biostat.jhsph.edu/courses/bio624/ );

• Biostatistics 160.651-654 (4 credits x 4 terms) – for quantitatively oriented PhD and master’s students who want advanced data analysis skills and who have working knowledge of calculus and linear/matrix algebra (websites: http://www.biostat.jhsph.edu/~courses/bio651/ ; http://www.biostat.jhsph.edu/~courses/bio652/ ; http://www.biostat.jhsph.edu/~courses/bio653/ ; http://www.biostat.jhsph.edu/~courses/bio654/ ).

To address the second issue, a two-term course sequence was jointly developed by faculty in the Departments of Biostatistics and Mental Hygiene to present quantitative approaches to measurement and theory construction in the context of multiple response variables in the behavioral and social sciences. These courses have been offered since the 1998-99 academic year:

o 330.657 Statistics for Psychosocial Research: Measurement (website: http://astor.som.jhmi.edu/~esg/statsforps.html )

o 140.658 Statistics for Psychosocial Research: Structural Models (website: http://astor.som.jhmi.edu/~esg/statsforps2.html )

The third issue of faculty availability for consultation with non-departmental doctoral candidates has been addressed in three ways. As the Biostatistics tenure-track faculty has increased in size from 12 to 16, its new members have become increasingly involved with students in other departments. Second, a model consulting program has been tested with the Department of Health Policy and Management in which a senior Biostatistics graduate student is funded to hold office hours for HPM graduate students at Hampton House twice per week. HPM also invites a Biostatistics faculty member to lecture in their proposal-writing course regarding biostatistical considerations. Finally, the department has created a free consultation period for all Hopkins community members every Friday morning from 10:30-12:00. Students who come receive 30 minutes of advice about statistical problems they confront.

26

5.2. Introductory Sequence for Laboratory Scientists: In our ongoing review of the new introductory biostatistics courses with faculty from across the School, we determined that there was an opportunity to better meet the needs of students from the laboratory science departments. A major issue was scheduling; laboratory science curricula were better served by a statistics course in the spring semester. There was also the desire for inclusion of some special design topics specific to laboratory science researchers.

We therefore worked with faculty representatives from BMB, MMI, and EHS to design an appropriate curriculum that we first implemented as Biostatistics 140.615-16 in terms and 4 of 2001-2. This course is being taught for the second time this year and we will determine whether it successfully meets the needs that motivated its creation.

5.3. Distance Education Courses: Another major accomplishment since the 1995 review is the role of the Department of Biostatistics in developing courses for internet-based students and maximizing the associated technology for delivery of these courses. Quantitative Methods in Public Health (550.692) was the first distance education course offered by the School (1997) and was co-developed by the Departments of Biostatistics and Epidemiology. Enrollment has increased from 30 to over 70 registrants per year since its inception. The Statistical Reasoning sequence (140.611-2) has been offered over the internet since 2000, receiving excellent reviews and enrollment of over 100 students. The MPH program expressed interest in having both 611-612 and 621-623 available to distance education students. Our faculty remain concerned that a web-based version of 621-623 would not achieve the same quality of learning as the in-person version because of the substantial component of data analysis skills involved. As a compromise, a set of two one-week intensive data analysis workshops has been developed (140.613-614) and offered during the Summer and Winter Institutes to provide data analysis skills and experiences for those students who have completed 611-612 on the web or in-person. These workshops have been given three times to date to classes of roughly 40 students. To maximize student learning, such a course requires four faculty members. The feedback to date has been extremely positive from both instructors and students. In addition to distance education, the department has played a major role in the educational programs for on-site education of part-time students: at the Montgomery County Center (MCC), in the Summer Institute for Epidemiology and Biostatistics, and in the new Winter Institute.

With these developments, the courses offered in these “non-traditional” venues include:

Courses currently offered via distance education: - Quantitative Methods in Public Health I-III; - Statistical Reasoning in Public Health I-II; - Introduction to Data Management and Statistical Computing.

27

Courses currently offered in the Summer Institute:

- Statistical Reasoning in Public Health I and II; - Regression Analysis; - Survival Analysis; - Data Analysis Workshop I and II; - Clinical Research Methods.

The Data Analysis Workshops I and II are also offered in the Winter Institute.

5.4. Educational Research: Individual students learn most efficiently by different methods: lectures, readings, problem sets, discussions, or by other means. To better serve a diverse group of students, the department seeks to expand the learning opportunities in its introductory courses. Toward this end, Marie Diener-West directed a PhD thesis by Felicity Boyd, who designed, conducted, and analyzed a randomized trial assessing two methods of active learning -- small group cooperative learning versus internet learning using computer applets -- as a supplement to lectures in Biostatistics 621-622 during the 2001-2002 academic year. This is the first randomized trial focusing on learning biostatistics. Although the analysis is ongoing, preliminary results indicate: 1) the supplementary modules offer a modest improvement; 2) we can predict those students who are greatest risk of poor performance in the course using a simple baseline screening instrument; and 3) that remedial mathematics training is likely to improve performance as much as additional statistical training. These findings, once verified, will be used to further improve and diversify learning of biostatistics at Johns Hopkins.

5.5. Service on Student Committees: Another way the faculty serve students in the School is through service on PhD examinations and thesis committees. During the 2001-2002 academic year, the 16 full-time faculty members of the department served on 52 preliminary exams and 46 final thesis committees/final oral examinations. This corresponds to roughly six exams per year per faculty member. As we would expect, senior faculty, with about ten exams per year, carry a greater fraction of the load.

5.6. MHS in Bioinformatics: With colleagues from MMI, Epidemiology, Oncology Biostatistics, Kennedy Krieger, and other Hopkins departments, we have developed a new MHS program in bioinformatics to be launched in the 2003-2004 academic year. The goal is to provide a one-year curriculum in genetics, computer science, statistics, genetic epidemiology and computational biology for two kinds of students: those with previous graduate education in one of these disciplines; and for college graduates without prior graduate training. The latter group will also be placed in a bioinformatics internship to further develop their practical skill set. The proposed curriculum is pictured in Figure 5.6 below. A distinguishing characteristic of the Hopkins program is its unified approach to genetic information, including molecular and population genetics. Hence, students will study not only sequence analysis, gene expression arrays, and proteomics, but also more traditional genetic epidemiology and statistical genetics.

28

To be successful, this program will require the creation of several new courses (shown in the figure by the boxes in bold). Instructors have been identified for nearly all of the courses. A new program in bioinformatics further accentuates the need for strong computational expertise within the department.

Success of this program will also depend on developing a tuition source to support students earning a PhD in one of the core disciplines. For this purpose, we are developing a training grant application for submission in the near future.

Pineda,Biostats Fac. Mtg. 12/13/02

Stats. for geneexpression

140.688

Molecular Biol.of Disease120.603

Wet Lab.260.lab

Proteomics260.pro

Special Topics140.spe

Scientific Computing

140.cs3

Prigge, Ruczinski, Pineda

Biostatistics & Epidemiology Molecular Biology Bioinformatics

Stats. III140.653

Stats. IV140.654

Methods ofGenetic Epi.

340.631

Methods ofGenetic Epi.

340.632

Pineda, et al.

Pineda, et al.

Non-coreelectives

Non-coreelectives

Non-coreelectives

1 credit requirements& electives

Broman, Caffo

Scott

Core bioinformatics curriculum

Quackenbush

Figure 5.6

Intro.Molecular Biol.

120.602

Intro. toBioinformatics

ME440.714

Biocomp. I140.cs1

Biocomp. IIDatabases/www

140.cs2

Pub. HlthPerspectives

550.865

Pub. HlthPerspectives

550.865

Seminar140.sem

Seminar140.sem

Stats. I140.651

Stats. II140.652

Bio. SequenceAnalysis140.seq

Ethics550.860

5.7. Issues/Future Directions in Statistical Education for Public Health Professionals and Scientists:

Enhancing Introductory Sequences: The new introductory biostatistics sequences have been offered since 1998. A Biostatistics faculty subcommittee has evaluated these courses in focus groups of randomly selected MPH, MHS and PhD students, and in meetings with departmental curriculum committees. Based on their feedback, we

29

have made some modifications to the curriculum. Among these changes is the design and initiation of a course sequence for laboratory scientists described above. In addition, we have identified the following ways in which student learning might be enhanced:

- Early identification of students at risk of poorer performance in introductory courses so they can address mathematics background deficiencies that might exist or receive additional tutoring early in the course sequence;

- Increased student opportunities to do realistic “projects” during the 623-4 series to better prepare them for their thesis research design and analysis;

- Increased diversity of learning opportunities by making available web-based applets and hands-on active learning “experiments” in addition to the lectures currently offered in the introductory sequences.

Educational Quality Across Offerings: Although courses are offered at multiple times, in multiple places, and in multiple modalities, the department faculty have strived to standardize the course content and quality. As an example, Statistical Reasoning is offered during first and second terms onsite and via distance education. The same examinations have been administered to both courses; the distributions of grades in the two courses have been similar.

Course websites have been developed for the large introductory statistics courses as well as for the distance education courses. Posting materials by class/topic on the website has resulted in modules that are easily transferable to shorter courses or lectures. An example of this is the use of Biostatistics 140.623 (Statistical Methods in Public Health) lecture modules during the one-week Regression Analysis course offered during the Summer Institute. An issue for the department is to maintain the highest quality of learning as the forms and modalities of our courses are modified to meet the needs of part-time and distance education students.

Coordinating Biostatistics and Epidemiology Sequences: The major overlap in content of courses occurs between the introductory biostatistics courses and the “first-year” courses offered by the Department of Epidemiology. Currently, the Department of Epidemiology is re-designing its first-year curriculum; coordination of topics between the introductory Biostatistics and Epidemiology sequences is desired. An example of the integration of both subjects is the distance education course Quantitative Methods in Public Health (550-692), which combines principles of epidemiology with exploratory data analysis, rates, basic probability concepts, life tables, and inferential techniques. Coordination of the offerings continues to be a priority for the future.

Informatics: The department has traditionally offered courses on database management and statistical computing (140.609) to MPH and other students. The MPH executive committee and the department have recently decided to discontinue this course. The department will consider future ways to expand courses on computer science topics important to quantitative analyses of public health information. The offerings related to bioinformatics are already being increased. We also would like to

30

enhance offerings related to databases and “reproducible research” related to clinical and population research. One course is planned for 4th term, 2003. Further planning in this area is needed to replace the core MPH course that was discontinued in 2002. We plan to coordinate with other department with related interests in public health informatics.

Short-courses for Non-Degree Audiences: At its last retreat, the department members decided to offer more short courses for non-degree-seeking students as a way to generate additional revenues and to disseminate statistical ideas to important audiences. Since then, we have taught courses for diverse audiences, including:

- J&J Pharmaceutical Research and Development; - Janssen Pharmaceutical Research Foundation; - US FDA; - US National Institute of Alcohol Abuse and Alcoholism.

A potentially important collaboration with FDA statisticians has also developed out of this short course planning. Three statistical leaders at FDA will soon become visiting scholars here. Our faculty and theirs have begun collaborations in key research issues related to the FDA mission.

6. Research: This section briefly reviews evidence of faculty productivity in research since the last review. We then summarize our thinking about upcoming opportunities. 6.1. Publications. The Department’s research is driven by faculty who identify and address important statistical and substantive problems, often in teams. Since our last review, faculty have continued to be productive, as measured by publications, funding from NIH and other competitive sources, and by awards. A complete list of the more than 300 refereed papers and 5 books authored by department faculty since the last review is available in Appendices 6-8 (http://www.biostat.jhsph.edu/self_study/appendix6.pdf; http://www.biostat.jhsph.edu/self_study/appendix7.pdf; http://www.biostat.jhsph.edu/self_study/appendix8.pdf) and on our website at http://www.biostat.jhsph.edu/biostat/publication/articles.shtml. Tables 6.1 and 6.2 summarize major publications by journal and year in the statistical and public health/biomedical literatures.

31

Table 6.1. Publications of Statistical Methodology Papers by Biostatistics Faculty* for the Period 1997-September 30, 2002

1997 1998 1999 2000 2001 2002 Total Am J Epidemiol

2 3 1 1 1 3 11

Am J Hum Genet

0 3 0 3 1 0 7

Biometrics

1 2 4 5 7 4 23

Biometrika

1 2 2 0 0 3 8

Biostatistics

-- -- -- 2 2 3 7

Genet Epidemiol

0 0 2 0 4 2 8

JASA

2 2 6 4 7 2 23

JRSS, A-C

3 1 1 2 1 1 9

Stat Med

1 2 2 2 0 3 10

Other

13 12 16 14 16 14 85

Total

23 27 34 33 39 35 191

* “faculty” includes all primary appointees plus Elizabeth Garrett, Steven Goodman, Giovanni Parmigiani, and Steven Piantadosi

32

Table 6.2. Publications in General and Specific Substantive Journals by Biostatistics Faculty* for the Period 1997-September 30, 2002

Number of Articles Per Year Journal Name 1997 1998 1999 2000 2001 2002 Total JAMA 2 3 1 1 1 1 9 Lancet 0 0 0 0 2 1 3 N Engl J Med 1 0 1 4 1 1 8 Nature 1 0 0 0 1 0 2 Proc Natl Acad Sci 0 0 0 0 0 1 1 Science 1 0 0 0 0 2 3 Total 5 3 2 5 5 6 26 Substantive Area Total Aging/Gerontology/Geriatrics 1 3 7 4 6 2 23 AIDS 5 2 2 3 3 0 15 Environmental Health 0 6 0 4 2 0 12 Genetics 3 1 2 5 10 5 26 Nephrology 0 2 1 2 4 1 10 Neurology 1 2 0 5 5 5 18 Oncology 10 12 18 10 21 13 84 Ophthalmology 12 5 3 2 6 3 31 Pediatrics 3 5 1 4 2 3 18 Psychiatry 1 0 1 4 6 2 14 Pulmonary/Respiratory Medicine 1 1 8 3 0 2 15

Total 37 39 43 46 65 36 266 * “faculty” includes all primary appointees plus Elizabeth Garrett, Steven Goodman, Giovanni Parmigiani, and Steven Piantadosi An additional method for our faculty to disseminate their findings is through the publication of books, a complete listing of which is available at http://www.biostat.jhsph.edu/biostat/publication/books.shtml. Since the last departmental review, seven new books have been published. 6.2. Biostatistics Grants. Over the period 1997-2002, the faculty have successfully competed as PIs for 17 grants from a variety of sources, as summarized in Table 6.3. In addition, they serve as co-investigators with collaborators in nearly every department

33

of the School and in a large fraction of departments in the medical school. Faculty fund the major portion of their own salaries and nearly all of their students’ stipends from external grants for which they and their collaborators successfully compete. Table 6.3. Faculty Grants/Contract Support.

Grant/Contract support ACTIVE PI Title Sponsor Purpose Start End Direct Total Brookmeyer Statistical Methods in Aids Research NICHD Research 8/1/1999 5/31/2003 $582,534 $959,985 Statistical Analysis of Risk Factors of Alzheimer’s Disease UCI Research 5/1/2002 4/30/2003 $60,502 $98,921 Statistical Models For Anthrax NIAID Research 9/30/2002 8/31/2004 $300,000 $490,500

Caffo Monte Carlo & Markov Chain Monte Carlo Algorithms Faculty Innov Research 5/1/2002 6/30/2003 $29,204 $29,204

Dominici Air Pollution & Daily Mortality in National Sampling HEI Research 1/1/2000 12/31/2002 $221,990 $299,541 Frangakis Statistical Methods For Partially Controlled Studies NEI Research 5/1/2002 4/30/2003 $175,000 $257,534 Liang Statistical Methods for Genetic Epidemiology NIGMS Research 12/1/2001 11/30/2005 $819,000 $1,339,064 Biostatistics Mental Health/Psychiatry Training NIMH Training 8/1/1998 6/30/2003 $880,342 $923,059

Louis Reaching The Uninsured through the Individual Market for Health Insurance Rand Research 7/1/2002 6/30/2003 $20,378 $33,318

Hierarchical Models in Health Services Research NIDDK Research 9/26/2002 8/31/2005 $369,000 $476,011 Improving Chronic Illness Care Evaluation (ICICE) Rand Research 7/1/2002 6/30/2003 $25,480 $41,660 Feasibility of Retinoid Treatment for Emphysema UMIN Research 8/1/2002 3/31/2003 $5,144 $8,411 Ruczinski Analysis of SNP Microarray Data Using Logic Regression MCRF Research 7/1/2002 6/30/2004 $100,000 $100,000

Using All-Atom Potentials to Improve Ab Initio Protein Structure Prediction

Faculty Innov Research 5/1/2002 6/30/2003 $25,488 $25,488

Scharfstein Analytic Methods for HIV Treatment and Cofactors Effects Harvard Research 8/15/2001 5/31/2003 $35,600 $58,315

Zeger Internet Health and Air Pollution Surveillance System (IHAPS): An Interactive System for Health Monitoring HEI Other 4/1/2002 3/31/2003 $193,433 $247,748

Statistics for Longitudinal Studies of Mental Health Services NIMH Research 8/15/1997 7/31/2003 $1,501,207 $2,412,039 Mental Retardation Research Center KKI Other 8/1/1998 7/31/2003 $136,460 $180,128 Sub-total $5,480,762 $7,980,926 TERMINATED in 1996-2002 Bandeen-Roche

Toward Alleviating Disability: New Quantitative Methods for Evaluation BFF Other 8/1/1997 7/31/1999 $120,115 $120,115

Broman Applications of Tree-Based Models to Identify Epistatic Interactions between QTLs in Organisms JHSPH Other 5/21/2001 6/30/2002 $26,689 $26,689

34

Brookmeyer Statistical Methods in AIDS Epidemiology NCI Research 9/1/1995 8/31/1999 $374,706 $626,106 Dominici Air Pollution & Mortality in Toronto and Philadelphia Ottawa Other 3/1/2000 9/30/2000 $10,000 $10,000

Frangakis Designs and Analyses to Address Deviations from Protocol in Studies of Human Subjects JHSPH Research 7/1/2002 6/30/2002 $28,175 $28,175

Irizarry Applications of Modern Time Series Techniques in Biomedical Sciences JHSPH Research 7/1/2000 6/30/2001 $27,336 $27,336

Lele Optimal Temporal Sampling Intervals for Detecting Landscape Vegetation Changes NASA Training 11/1/2009 10/31/1996 $88,000 $88,000

Extension and Enhancement of Methods for Setting Data Quality Objectives MSU Other 1/1/1996 8/31/1996 $23,943 $31,605

Liang Statistical Methods for Genetic Epidemiology NIGMS Research 8/1/1993 11/30/1997 $503,360 $838,604 Statistical Methods for Genetic Epidemiology NIGMS Research 12/1/1997 11/30/2001 $588,309 $944,512 Rohde Community Prevention Interventions for Urban Demolitions KKI Research 10/15/2000 8/31/2002 $9,449 $16,287 Biostatistics Mental Health/Psychiatry Training NIMH Training 7/1/1993 6/30/1998 $581,961 $611,375 Scharfstein Analytic Methods for HIV Treatment and Cofactors Effects Harvard Research 8/1/1998 7/31/2001 $72,830 $117,984

Incorporating Model Uncertainty into Analysis of Randomized Trials with Non-Compliance JHSPH Research 5/1/2002 6/30/2002 $25,000 $25,000

Wang Statistical Methods Designs NIAID Research 4/1/1993 3/31/1996 $173,158 $286,080 Analytical Methods for Observational Drug User Cohorts NIDA Research 7/1/1997 5/31/2001 $966,177 $1,306,621 Beta Interferon Arm of ALD Thalidomide Study KKI Research 9/30/1997 9/29/1999 $11,082 $13,853

Studies of Glyceryl Trierucate Therapy of Adenoleukodystrophy KKI Research 9/30/1997 9/29/2000 $33,747 $42,185

Zeger Identification of Current Statistical Practices JP Other 1/1/2000 12/31/2000 $99,000 $99,000 Identification of Current Statistical Practices JP Other 1/1/1996 012/31/96 $50,000 $50,000 Mental Retardation Research Center KKI Other 9/1/1996 7/31/1998 $38,661 $51,032 Identification of Current Statistical Practices JP Other 1/1/1997 12/31/1998 $198,000 $198,000 A Symposium of Longitudinal Study of Quality of Life JRF Other 10/1/1998 6/30/1999 $80,418 $88,460 Identification of Current Statistical Practices JP Other 1/1/1999 12/31/1999 $99,000 $99,000 Biostatistics Shared Instrumentation Grant NIH Other 4/1/2000 3/31/2001 $313,995 $313,995 Sub-total $4,543,111 $6,060,014

35

Table 6.4 Editorships/Associate Editorships

Karen Bandeen-Roche: Associate Editor, Biometrics, current Associate Editor, JASA Applications and Case Studies, current Ron Brookmeyer: Statistical Consultant, Science, 2001-present Associate Editor, JASA Applications and Case Studies, 1997-2002 Associate Editor, Biostatistics, 1999-2001 Editorial Board, Statistics in Medicine, 1986-1995 Editorial Board, Controlled Clinical Trials, 1983-1987 Marie Diener-West: Associate Editor, Journal of General Internal Medicine, 1999-Present Editorial Board, American Journal of Ophthalmology, 1998-Present Statistical Reviewer, Radiology, 1986-1994 Francesca Dominici: Statistical Editor, American Journal of Epidemiology, 2002-present Rafael Irizarry: Associate Editor, Biostatistics, 2002-present Kung-Yee Liang: Associate Editor, Biostatistics, 1999-2003 Associate Editor, Biometrics, 1994-2000 Associate Editor, Statistica Sinica, 1988-1993 Associate Editor, JASA Applications and Case Studies, 1988-1991 Tom Louis: Editor, JASA Applications and Case Studies and JASA Coordinating, 2001-2003 Co-editor, formula funds allocation, special issue of the Journal of Official Statistics, 2002 Associate Editor, Controlled Clinical Trials, 1999-2000 Editor, Statistical Science, 1998-2000 Editorial Board, Applied Stochastic Models in Business and Industry, 1999 Associate Editor, Statistica Neerlandica, 1996-1999 Co-Editor, CHANCE, 1992-1998 Editorial Board, Chapman & Hall Series on Statistics and Applied Probability, 1997 Editorial Board, ASA-SIAM Series on Statistics

and Applied Probability, 1993-1995 Editorial Board, Statistics in Medicine, 1989-1994 Associate Editor, JASA Theory and Methods, 1988-1991 Giovanni Parmigiani: Associate Editor, Biometrics, 2000-present Member, Editorial Board, Medical Decision Making, 1999-present Associate Editor, JASA Theory and Methods, 1999-2002 Charles Rohde: Editorial Advisory Board, Journal of Environmental Statistics, 1993-present Daniel Scharfstein: Associate Editor, Biometrics, 1999-present Mei-Cheng Wang Associate Editor, JASA Theory and Methods, 1999-present Associate Editor, Journal of Lifetime Data Models, 1994-present Associate Editor, Biometrics, 1997-1999 Associate Editor, JASA Applications, 1996-1997 Scott Zeger: Co-Editor, Biostatistics, 1998-present Editorial Board, Springer Series in Statistics and Springer Lecture Notes in Statistics, Springer Press, 1995-present Statistical consultant to Science, 2001-2002 Associate Editor, Journal of the American Statistical Association, 1988-1997

36

Table 6.5. Membership on Special Committees/Panels/Study Sections:

Karen Bandeen-Roche: Representative, AAAS Medical Science Section, Internatl Biometrics Society/Eastern North American Region (IBS/ENAR), 2003-2005 Consultant, FDA panel on ophthalmic devices, 1997-present Program Ctte Member, Spring Mtg of IBS/ENAR, 2003 Chair, Snedecor Award Ctte, Ctte of Statistical Societies, 2002-3 SNEM5 (statistics) study section, NIMH, 2002 Secretary, IBS/ENAR, 2001-2002 Snedecor Award Ctte, Ctte of Presidents of Statistical Societies, 2001-2 Student Paper Award Ctte, IBS/ENAR, 2001 NIMH study section, 2000 Representative, IBS/ENAR Regional Advisory Board, 1996-98 Biometrics Representative to Council on Sections, ASA, 1995-97 Publications Officer, Biometrics Section, ASA, 1993-94 Ron Brookmeyer Biometrics Society (ENAR) Student Awards Ctte, 2002 External Advisory Ctte, Mayo Clinic Alzheimer’s Disease Patient Registry, 2001 Consultant, Estimating HIV Incidence, CDC, 2001 Planning Ctte, CDC Mtg on Antiretroviral Therapy & AIDS Prevention, 2000 Ctte to Review Social Security Admin’s Disability Decision Process, Inst of Medicine, 1996-2000 Scientific Advisory Board, Women, Infants HIV Transmission Study, NIH, 1999 Co-Organizer, Workshop on Quantitative Evaluation of HIV Prevention Programs, NIDA and SIMS, 1998 Joint Fellowship Review Board, ASA/Natl Ctr for Health Stats, 1998 Ctte on Perinatal Transmission of AIDS, Institute of Medicine, 1997-1998 Awards Ctte, Ctte of Presidents of Statistical Societies (COPSS), 1996-1998 Advisory Group to NCI’s Study of Electromagnetic Field Exposure and Childhood Acute Lymphocytic Leukemia, 1994-1997 Chair, David P. Byar Young Investigator Award Ctte, 1996 Organizer, Invited Paper Session: AIDS in the 1990s, International Biometrics Conference, 1996 Chair, Biometrics Section of the ASA, 1995 Panel on Needle Exchange Programs, Natl Acad of Sciences, 1993-1995 Biometrics Society Liaison to the ASA, 1994 Workshop on Modeling and Forecasting AIDS, CDC, 1988, 1989, 1991, 1994 Scientific Review Panel of the AIDS Clinical Trial Group, NIAID, 1993 Organizer/Chair, Invited Paper Session: Statistical Problems in Infectious Diseases, APHA, 1993 Regional Ctte of the Biometrics Society (Elected), 1989-1992Clinical Research Subctte, AIDS Research Advisory Ctte, NIAID, 1990-1991 Ctte on Natl Statistics, Natl Research Council & Natl Acad of Sciences, 1988-1991 Program Chair, Biometrics Society Meeting (ENAR), 1990 Visiting Fellow, Natl Ctr for Epidemiology & Population Health, Australian Natl University, 1990 Organizer/Chair, Invited Paper Session, Statistical Analysis of Infectious Diseases Data, Joint Statistical Mtgs, 1989 Regional Advisory Board, Biometrics Society, 1986-1989

Panel on Statistical Issues in AIDS Research, Natl Acad of Sciences, 1988 Expert Review Panel on HIV Seroprevalence & AIDS Projection Methodology, NYC Dept of Health, 1988 Organizer/Chair of Invited Paper Session, Statistical Problems in Epidemiology, Biometrics Society Mtg, 1988 Chair, Organizing Ctte, Conf on Statistical & Mathematical Modeling of the AIDS Epidemic, JHU and the Alfred P. Sloan Foundation, 1987 Workshop on Modeling the Spread of Infection with HIV, Institute of Medicine, 1987 Subctte of the Scientific Advisory Board, EPA, 1985, 1986 Site Visit Team, NCI, 1985 Consultant, EPA, 1984 Site Visit Team, Natl Inst of Neurological & Communicative Disorders, 1983 NIH Special Study Section-Biostatistics, 1983 Consultant, FAA, 1981 Marie Diener-West: Member, Review Ctte for Therapeutic Development Centers, Cystic Fibrosis Foundation Data and Safety Monitoring Board, Dosing and Safety Trials using Cyclosporin A in Severe Head Injury, National Institute of Neurological and Communicative Disorders and Stroke, 2001-present Data and Safety Monitoring Ctte, Detection Acceptability Intervention for STDs among Youth, (AHRQ), 2001-present External Advisory Ctte, Dialysis Access Consortium, National Institute of Diabetes and Digestive and Kidney Diseases, 2001-present Institutional Review Board Member, Clinical Trials and Surveys Corp., 2001-present Board Member, Delta Omega Society, Alpha Chapter, 2001-present Data and Safety Monitoring Ctte, Age-Related Macular Degeneration Radiotherapy Trial, Natl Eye Institute, 2000-present Board of Directors, Soc for Clinical Trials, 1999-present Member, Veterans Admin Cooperative Studies Evaluation Ctte, 1998-present Member, Cystic Fibrosis Foundation Clinical Research Ctte, 1997-present Data and Safety Monitoring Ctte, Radiation Therapy Oncology Group, NCI, 1993-present Member, Surgery Branch Review Ctte, Div of Clinical Sciences, NCI, 2000 Member, Emphasis Panel, Natl Institute of Diabetes and Digestive and Kidney Diseases, 2000 Data Monitoring Ctte, VA Hearing Aid Trial, Veterans Administration, 1995-1999 Member/Reviewer, Study Sect for the Foundation for Chiropractic Education and Research, 1987-1997 Ad Hoc Member, DHHS, NIH Div of Research Grants, Special Study Section, 1994 Ad Hoc Member, Research Training Review Ctte, NHLBI, 1991 Member, Special Review Ctte, Natl Institute of Neurological and Communicative Disorders & Stroke, 1988 Francesca Dominici: Natl Acad of Sci Ctte studying the potential health effects of the PAVE PAWS radar in Cape Cod, MA, 2002-present Member, EPA panel study section, 2001 Elizabeth Garrett: Member, Ad hoc review ctte for the California Breast Cancer Research Prog, 2002

37

Rafael Irizarry: Reviewer, Taiwan's National Science Council's National Research Program for Genomic Medicine Tom Louis: Panel to review guidelines for thrombolysis treatment of acute ischemic stroke, 2002-present NIH ad hoc group to promote increased funding for training in Biostatistics, 2001-present Data and Safety Monitoring Board, the Dialysis Access Consortium, 2001-present Health Review Ctte, Health Effects Inst, 2000-present Diesel Emissions Project Ctte, Health Effects Inst, 2000-present Advisory Ctte, Cardiac Vulnerability Related to Particulate Matter Project, 2000-present Advisory Ctte EPA/Harvard Center on Ambient Particle Health Effects, 2000-present Advisory Board, Ctr for Innovation in Clinical Research, M.D. Anderson Cancer Ctr, 2000-present Steering Ctte, US Renal Data System, 2000-present Chair, Data and Safety Monitoring Board, Chemoprevention of Skin Cancers with DFMO Clinical Trial, 1998-present NAS, Ctte on National Statistics, 1997-present Advisory Board, Institute of Medicine (IOM), Medical Follow-up Agency, 1996-present Chair, Ctte to review Biostatistics at Emory U, 2002 Ctte to propose a statistics editor for Science magazine, 2001 Advisory Ctte for the Program in Environmental Statistics, Dept of Biostatistics, Harvard School of Public Health, 2001 Panelist, NIH Consensus Conference on Adjuvant Therapy for Breast, Cancer, 2000 Oversight Ctte, HEI, National Morbidity and Mortality Air Pollution Study, 1997-1999 NAS, Panel on Estimates of Poverty for Small Geographic Areas, 1996-1999 NIH Special Emphasis Panel Proposal Review, 1998 Chair, NIAID review panel, Statistical Center, Women's Interagency Health Study, 1997 Advisory panel, U Chicago Dept. OB/GYN, issues in stopping a clinical trial, 1997 DSMB, Long-term outcome of Obesity Treatment in Minority Women Study, 1993-1997 IOM/MFUA Ctte to Review the Health Consequences of Service during the Persian Gulf War, 1994-1996 UCLA Visiting ctte on reorganizing statistics, 1995 Visiting Ctte, Cleveland Clinic Dept of Epidemiology and Biostatistics, 1995 Advisory Ctte for Research Synthesis, The Russell Sage Foundation, 1987-1993 AHCPR Health Care Technology Study Section, 1988-1990 EPA Health Effects Scientific Review Panel, 1984-1988 Advisory Ctte, Kidney Transplant and Histocompatibility Study, 1981-1983 Giovanni Parmigiani: Grant proposal reviewer for: Natl Science Foundation; Alberta Heritage Found for Medical Research; Dept of Higher Education and Scientific Research, Italy; Natl Coordinating Ctr for Health Technology Assessment NIH Study Sessions: CA-99-013 "Cancer Surveillance Modeling Network (CISNET)" NIH Site Visits: P01 "Statistical Methods for Medical Studies", U of Washington Member, NCI's Cancer Family Registries' Biostatistics and Genetic Epidemiology Team, 2000-present American Cancer Society's “Breast Cancer Risk Communication'' workshop and consensus statement, 1999 Charles Rohde: Member, FDA Panel, 1994-1999 Member, Oral Biology & Medicine Study Section (ad hoc

review section), NIDR, 1977-1994 Ad hoc consultant, Natl Institute of Dental Research, 1969-1994 Chair, Ctte on Statistics & the Environment, ASA, 1982-1983 Member, Panel on Quality Criteria for Water Reuse, Natl Research Council Assembly of Engineering, 1980-1982 Chair, ASA Subsection on Teaching of Statistics in the Health Sciences, 1978 Consultant, Information Processing Div, Goddard Div, NASA, 1965-1968 Daniel Scharfstein: Member, ENAR Regional Advisory Board, current IMS Program Chair for ENAR, 2003 James Tonascia Member, Data and Safety Monitoring Board for CARE Asthma Clinical Research Network, NHLBI, current Member, Data and Safety Monitoring Board for Ulcerative Colitis Multi-Center Clinical Trial, NIDDK, current Mei-Cheng Wang Reviewer, Special Review Sections, AIDS & Related Research Study Section 2, NIH, 1993-present Reviewer, Service Research Review Ctte, NIMH, 1993-present Reviewer, Special Review Sections, Grant proposals for the NSF, 1990-present Board Director, Intl Chinese Student Assoc (ICSA), 2000-2002 Chair, ICSA Nomination Ctte, 1999, 2000 Chair, ICSA Publication Ctte, 1999 Program Chair, ICSA Mtg at ASA Mtgs, 1999 Appointed Member, AIDS & Related Research Study Section 2, NIH, 1994-1998 Program Chair of ENAR for ASA Mtgs, 1996 Scott Zeger: Member, U of Chicago Ctr for Environmental Statistics Advisory Board, 2001-present Member, Institute of Medicine Panel on Risk Benefit Analyses, 2001-present Expert witness, US Department of Justice, in civil suits against the tobacco companies, 1999-present Member, Merck Research Laboratories Board of Scientific Advisors 1995-present Member, Scientific Advisory Board, U of Southern California Children's Health Study 1992-present Member, Dana Farber/Harvard Cancer Center External Advisory Board, 2001 Member, Inst of Medicine Panel on Gulf War Illness, 1999-2000 Expert witness, States of MN, WI, & MD, in civil suits against the tobacco companies, 1998-1999 President, International Biometric Society Eastern North American Region (ENAR) 1996-1997 Member, Board of Trustees of the Natl Inst of Statistical Sciences 1995-1996 Member, Regional Advisory Board, International Biometric Society, Eastern North American Region 1988-1993 Scientific Review Panel, EPA, 1985-1989

38

6.3. Faculty Awards/Recognitions: Since the last review, department faculty have been honored with Golden Apples, AMTRAs, the Award for Best Distance Education Instructor, Faculty Innovation Awards, and fellowships of the American Association for Advancement of Science, Brookdale Foundation, and the American Statistical Association. They have won the Snedecor and Noether awards for best young researchers in biostatistics. Their papers have been chosen as “best” in the Journal of the American Statistical Association, Genetic Epidemiology and by the epidemiology section of the ASA. A complete list of faculty awards is available at http://www.biostat.jhsph.edu/biostat/award/. Faculty have also been elected to be editors and associate editors of the world’s leading biostatistics journals, as shown in Table 6.4, and have been invited to serve their profession in various special committees, panels, and study sections as shown in Table 6.5. 6.4. Future Research Directions: While individual faculty choose specific directions for research, there is a collective planning process at annual retreats where we discuss areas for growth in our research program over the next three to five years. At our most recent retreat, we identified four areas summarized below. Genetics: The faculty propose to continue to build research strength in statistical methods for genetics, including genetic epidemiology, statistical genetics and bioinformatics. We are forming the Hopkins Genome Biometry Laboratory (GBL) to develop and apply advanced methods in bioinformatics/biostatistics that support molecular and population genetics research at our medical institutions and beyond. The GBL will provide physical space integrated within the department and the requisite computational resources for faculty and students to pursue computational and statistical issues in the design and analysis of data from basic biological studies. The department has a strong group of young faculty interested in this area and plans to recruit new faculty members with expertise in computational statistics and bioinformatics. The group will closely collaborate with the Departments of Biochemistry and Molecular Biology, Molecular Microbiology and Immunology, Epidemiology, Environmental Health Sciences, and with School of Medicine colleagues in Oncology and the Institute for Human Genetics. It will have joint responsibility for building the bioinformatics team for the Malaria Initiative. A key opportunity will be fostering closer collaborations with colleagues at the Institute for Genomic Research (TIGR). Dr. John Quackenbush from TIGR is joining our department as an adjunct associate professor and will play a key role in the new MHS program in bioinformatics.

The department will also continue to build its strength in statistical genetics, collaborating closely with colleagues in Epidemiology and at the NIH’s Center for Inherited Disease Research (CIDR). Hopkins seeks to be a leader in statistical methods for genetics with a broad spectrum of applications from molecular to population genetics, seeking a synthesis in methods wherever possible.

Health Surveillance: The department plans to expand and coordinate the development and application of a set of related statistical methods for tracking population health and

39

disease. We refer to these, collectively, as problems of "health surveillance." A key issue common to these problems is how best to integrate and interpret information possibly derived from multiple sources.

The department faculty will focus on statistical issues that arise in diverse settings, including the surveillance of:

• epidemics (HIV; Alzheimers disease; bioterrorist outbreaks of anthrax or smallpox); • environmental risk factors (smoking, air pollution and weather) and the resulting

morbidity, mortality, and medical expenditures; • chronic diseases such as cardiovascular disease, cancer, and mental disorders

(schizophrenia and depression); • natural processes such as children’s development and aging; • medical services and their consequences.

Social science methodology is key for the last two issues. The diversity of the aforementioned problems demonstrates the potential for an innovation to have a major impact. We propose to move novel methods directly to web platforms so that they can be widely used by the public health community. Doing so will create new models for surveillance. Success in this area requires further strengthening of faculty and staff in informatics and computer science. For one recent example, see http://biosun01.biostat.jhsph.edu/~ririzarr/Raffy/index.html

Clinical and Community Trials: The department will continue to specialize in the design and analysis of clinical and community studies -- in particular, randomized trials. Working as members of the Johns Hopkins Center for Clinical Trials (JHCCT), our faculty will develop and implement effective designs and methods for the successful conduct of studies and analysis of data from randomized trials. Modern clinical trials are producing increasingly complex markers of disease status, including images and gene expression arrays. Investigators seek to go beyond traditional intent-to-treat methods to estimate the biological efficacy of therapies, account for non-compliance, and deal more successfully with study drop-outs. As genetic typing advances, clinical scientists will seek to identify subgroups for which particular treatments are most effective. Ultimately, we will attempt to predict the efficacy of a new treatment for each individual using genetic and other biomarkers. With this increasing complexity, a key question is how best to conduct trials to ensure the reproducibility and validity of the evidence they produce.

In community trials, similar questions pertain. In addition, distinguishing the contributions of personal, family, neighborhood, and regional influences on health using multi-level designs and analyses is of interest.

40

Foundations of Research Methodology: The design of empirical studies and analysis of their data to draw valid scientific inferences is the central methodology of public health and biomedical research. The department will further strengthen our research on the foundations of scientific inferences focusing on novel approaches to the design and analysis of observational studies, the cornerstone of epidemiologic research. We will build on the department’s tradition established by William Cochran and Jerome Cornfield and led in recent years by Richard Royall. Key research areas are likelihood inference, Bayesian biostatistics, and causal inference from observational data. Recent additions to the faculty bring strength for future research on foundations. Each of the four initiatives introduced above critically depends on a state-of-the-art statistical computing environment including hardware, software, and personnel. We plan to recruit additional faculty and staff with interests in databases and web-based technologies, including one person to take responsibility for leading an initiative in “reproducible research” and in teaching public health informatics from a biostatistical perspective. 7. Consulting Center: The mission of the Johns Hopkins Biostatistics Center is to provide biostatistical and information science expertise in support of health research to investigators at Johns Hopkins University and other academic health centers, government agencies, and private organizations who do not have longer-term collaborative relationships with biostatistical faculty here or elsewhere. The Center’s doctoral and master’s-level statisticians and computer scientists consult on research issues related to the effective collection, management, and interpretation of scientific information, including:

• Designing research studies, data collection systems and instruments; • Data entry and validation; • Data management and quality assurance; • Statistical analysis and data interpretation; • Professional and scientific report writing.

Scott Zeger currently serves as the Center’s Acting Director; Assistant Scientist Richard Thompson, the Associate Director, is responsible for day-to-day operations. A Board of Advisors representing biostatisticians and medical scientists from the Schools of Medicine, Nursing, and Public Health and from the Johns Hopkins Health System supports the strategic planning for the Center and insures that the services provided meet the needs of the research community. Requests for services can be made by email (stathelp@jhsph.edu), telephone, or fax to Debra Moffitt, Center Coordinator. Within a few hours, Ms. Moffitt arranges a preliminary meeting with the Director or Associate Director to plan the consulting services with the client and estimate their costs. Center work is conducted by master’s and doctoral-level consultants, all of whom are employees of the Johns Hopkins

41

University. Table 7.1 lists the current members of the Center’s Board of Advisors and Center staff.

Table 7.1. Johns Hopkins Biostatistics Center: Advisory Board and Staff

Advisory Board Members:

Scott L. Zeger PhD Professor and Chair Biostatistics Jerilyn Allen ScD Professor and Director PhD Program – School of

Nursing James Tonascia PhD Professor Biostatistics Josef Coresh MD, PhD Assistant Professor Epidemiology Steven Goodman MD, MS,

PhD Associate Professor Oncology

Lee Fleisher MD Professor Anesthesiolgy & Crit Care Eric Bass MD Associate Professor Department of Medicine Sharon Krag PhD Associate Dean Graduate Education &

Research Steven Piantadosi MD, PhD Professor Oncology Center Staff:

Scott L. Zeger PhD Director Richard Thompson PhD Associate Director Elizabeth Johnson MS Statistician Sarah Barry MS Statistician John McGready MS Statistician Michele Donithan MHS Technical Andre Hackman BA Technical Jiong Yang MS Computer Scientist Christopher McCullough BS Financial Coordinator Debra Moffitt MS Administrative

Coordinator

As shown in Table 7.2, total revenues are roughly $250-300,000 per year, with FY01 being an outlier due to a large project for the U.S. Justice Department in their civil action against tobacco companies. Of the total revenues, roughly three-quarters are from outside clients.

42

Table 7.2. Johns Hopkins Biostatistics Center: Revenue Summary by Client Category in US Dollars

FY98 FY99 FY00 FY01 FY02 TOTAL

JHMI 56,274 71,304 94,238 95,466 83,800 401,082

External 10,577 114,037 198,367 400,485 188,538 912,004

Total 66,851 185,341 292,605 495,951 272,338 $1,313,086

While most of the revenues derive from external clients, the large majority of clients are internal to Johns Hopkins, as summarized in Table 7.3 below. Table 7.3 also shows the broad range of Hopkins programs and departments that have been served by the Center at very modest aggregate cost. The Center seeks to be involved in projects that lead to scientific publications. Appendix 9 (http://www.biostat.jhsph.edu/self_study/appendix9.pdf) gives a partial list of publications and grant applications in which they have been participants.

43

Table 7.3. Johns Hopkins Biostatistics Center: Projects by Department and Year.

TOTAL 1/1/00 - 12/31/00 1/1/2001 - 12/31/01 1996 - 12/30/0 SOM Dean's Office 0 0 2 Anesthesiology (ACCM) 1 1 4 Asthma & Allergy 1 1 3 Biomedical Engineering 0 0 1 Cardiology/Cardiovascul 2 1 7 Gastroenterology 1 0 4 Geriatric Medicine 0 0 4 Hematology 1 0 1 Infectious Diseases 1 0 3 Internal Medicine 2 0 7 Medicine (General) 0 1 6 Molecular Biology 0 1 2 Neurology 2 4 9 Neurosurgery/radiology 0 0 3 OB/GYN 3 1 21 Orthopedic surgery 1 0 2 Pathology 2 4 7 Pediatrics 3 2 14 Pharmacy 0 1 1 Phys Med. & Rehab 2 0 2 Psychiatry 4 4 12 Radiology 1 0 5 Rheumatology 3 3 8 Surgery 0 1 1 Ophthalmology 2 1 4 Other 1 1 3 Bayview Varied 1 1 3 SON Varied 2 2 4 BSPH Dean's Office 0 1 1 EHS 1 0 2 EPI 2 0 2 HPM 1 1 7 IH 0 3 3 MMI 0 0 2 P&FH 0 1 1 Other 1 0 2 KKI 11 2 26 Internal (Subtotal) 52 38 189 External (Subtotal) 8 15 35

44

45

Consulting Center Walk-In Clinic: The Center has held a free walk-in clinic every week for over two years. The clinic was created to serve students, postdoctoral fellow, and other Hopkins affiliated researchers who do not have funding for their projects.

Held every Friday from 10:30 AM to 12 noon, the clinic always has on call two master’s or PhD-level statisticians, with rotation among five regular faculty members and one PhD student. Individual consultations with clients vary in length, with each client having a minimum of a half-hour. Clients present a range of questions regarding their current projects and theses, including methodology, programming, and interpretation of findings.

Year 1 had a total of 52 clinics in which 95 clients made 151 visits. In Year 2, 107 clients made 170 visits in only 47 clinics.

8. Shorter-term Action Items: As a final summary, we list steps identified in this self-study that the department can take in the next year or two to further strengthen itself.

1. Continue to improve our introductory-level sequences, incorporating the lessons derived from our recent randomized trial of learning modalities.

2. Submit training grants in: environmental biostatistics; bioinformatics, and biostatistics for undergraduates;

3. Develop a plan to attract a diverse group of candidates to our PhD program; 4. Appoint a faculty director of the MHS program to better mentor students -- in

particular those in the joint MHS-PhD program; 5. Add two faculty -- a new PhD biostatistician and a statistician or computer scientist --

to lead our research and education on statistical computing and support the MHS program in bioinformatics;

6. Successfully launch the MHS program in bioinformatics; 7. Complete the move to our new space, thus alleviating the space problems for

graduate students, expanding and upgrading the library and conference room, and creating the Genome Biometry Laboratory.