Rajeshwari Sridhara, Ph.D.
Director, Division of Biometrics V Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Dr. Sridhara is the director of the division of biometrics V in the Office of Biostatistics which supports the Office of Hematology oOncology Products and the Office of Drug Evaluation IV (medical imaging products) at the Center for Drug Evaluation and Research (CDER) of the U.S. Federal Drug Administration (FDA). She routinely presents the regulatory policies and scientific philosophy of the office at national and international professional meetings.
Dr. Sridhara has contributed to the understanding of statistical issues unique to the area of oncology disease such as evaluation and analysis of time to disease progression. Her research interests also include evaluation of surrogate markers and design of clinical trials. She has organized, chaired and given invited presentations at several workshops, and has worked on regulatory guidance documents across multiple disciplines. She has reviewed many high-profile drug applications and has made several presentations at the oncology drug advisory committee meetings. She has published extensively in refereed journals and presented at national and international conferences.
Prior to joining the FDA, Dr. Sridhara was a project statistician for the AIDS vaccine evaluation group at EMMES Corporation and was an assistant professor at the University of Maryland Cancer Center. She is a member of the American Statistical Association and the American Society of Clinical Oncology.