ary A. Foulkes, Ph.D., Research Professor, Department of
Epidemiology and Biostatistics joined the Biostatistics
Center in 2007. She currently serves as Deputy Director for the
Type 1 Diabetes TrialNet
Coordinating Center. 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.
r. 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 has served as an Instructor for the
London School of Hygiene and Tropical Medicine.
n 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 Statistical Association
(ASA), and has received the ASA Founders' Award.
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