American Statistical Association New York City Metropolitan Area Chapter Mailman School of Public Health Columbia University Department of Biostatistics Colloquium

Who are the statisticians at the FDA? What do they do? When and where do they work? How many are there? Why do they find their careers so interesting? FDA statisticians are involved in a broad range of the Agency’s activities in the regulation of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. Janice Derr will describe the activities of statisticians who work at the Center for Drug Evaluation and Research. She will describe how FDA statisticians work in multi-disciplinary teams, review and evaluate statistical approaches to problems, help set standards, and conduct research on statistical aspects of the regulatory process.

Janice Derr is a statistician with the U.S. Food and Drug Administration (FDA), at the Center for Drug Evaluation and Research (CDER). She joined the FDA in 1998. Prior to that, she was Managing Director of the Statistical Consulting Center at Penn State University. She taught the graduate student course in statistical consulting. Dr. Derr has a Ph.D. in biology and a master's degree in statistics. She helped to organize the ASA Section on Statistical Consulting and served as its chair in 1999.