Steven Anderson

Steven Anderson, Ph.D., M.P.P., is currently the Director of the Office of Biostatistics and Pharmacovigilance (OBPV) at the FDA Center for Biologics Evaluation and Research (CBER), United States of America. He provides leadership for all CBER statistical, epidemiological and surveillance programs and has led numerous important surveillance and epidemiological studies and quantitative benefit-risk assessments of vaccines, advanced therapies, and blood products using systems such as VAERS (Vaccine Adverse Event Reporting System), the FDA BEST (Biologics Effectiveness and Safety) system and CMS (Center for Medicare and Medicaid Services) data. In 2017, Dr. Anderson led CBER efforts to launch the BEST system, CBER’s new postmarket risk identification and analysis system that engages new data sources, tools, new innovative technologies such as artificial intelligence, and experts to further enhance biologic product effectiveness and safety surveillance.

Dr. Anderson earned a Master’s Degree in Public Policy (MPP) at Georgetown University and his PhD from the University of Cincinnati where he worked in the areas of biochemistry, drug resistance and ion pumps, pathogenicity and genomics of unique tropical disease pathogens. He has published a number of articles in biologic product safety, surveillance, risk assessment, epidemiology, infectious diseases, biologics safety, and genomics.