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esearch Professor, Department of Epidemiology and Biostatistics, and
Department of Health Policy, joined the Biostatistics Center in 2007. She
currently serves as Senior Statistician for the Diabetes Prevention Program
(DPP).
She was formerly the Director of the Office of Biostatistics and
Epidemiology, Center for Biologics Evaluation and Research, FDA. She headed the
internal FDA working group that developed the DMC guidance document, published
in 2006 in the Federal Register. Among prior positions, she served as Chief of
the Biostatistics Research Branch, Division of AIDS, National Institute of
Allergy and Infectious Diseases (NIAID). She received the FDA Commissioner's
Special Citation Award for Anthrax Vaccine Final Order in 2006, the DHHS
Secretary's Award for Distinguished Service for Patient Safety in 2003, and was
appointed to PHS Senior Biomedical Research Service (SBRS) in 1999. She has
twice received the NIH Director's Award in 1996 in recognition of her work in
advancing HIV therapeutic trials, and in 1992 for statistical methods applied
to outcome studies in stroke and traumatic head injury. Dr. Foulkes received
her Ph.D. in biostatistics from the University of North Carolina at Chapel
Hill.
Dr. Foulkes has published in both the statistical and medical literature on
topics such as clinical trial design, analysis of longitudinal data, and data
monitoring committees. She is an Associate Editor for the Journal of the
American Statistical Association (JASA) and the Journal of the National Cancer
Institute (JNCI). She is also a Faculty Associate with the Johns Hopkins
University Bloomberg School of Public Health Department of Biostatistics, and
serves as an Instructor for the London School of Hygiene and Tropical Medicine.
In a variety of positions in academia, private industry and government, Dr.
Foulkes has collaborated on numerous randomized, controlled clinical trials in
cardiovascular disease, infectious diseases, neurological disorders, oncologic
therapies, and in disease prevention. She has participated in the design,
conduct, interim monitoring, analysis, reporting and/or regulatory
interpretation of these trials. She has served on a number of Data Monitoring
Committees for NIH, MRC and VA-sponsored trials. Dr. Foulkes is a Fellow of the
American Association for the Advancement of Sicence (AAAS), a Fellow of the
American Statistical Association (ASA), and has received the ASA Founders'
Award.
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