John Scott (BIOST '08) was recently appointed as the director of the Division of Biostatistics at the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research. Pitt Public Health and particularly the Department of Biostatistics congratulates Scott for his new role as the division leader.
In this role, Scott leads a group of 35 biostatisticians responsible for statistical aspects of the regulatory evaluation and oversight of vaccines, allergenic extracts, blood components, cellular therapies, gene therapies, and other advanced biological products. He has contributed to many of the FDA's statistical policy efforts over the past decade, including the 2017 Guidance on Multiple Endpoints in Clinical Trials, the 2018 Guidance on Adaptive Designs for Clinical Trials of Drugs and Biologics, and the in-progress ICH E9(R1) guideline on Estimands and Sensitivity Analysis in Clinical Trials.
Prior to joining the FDA in 2008, Scott was a statistician at the Western Psychiatric Institute and Clinic at the University of Pittsburgh Medical Center, where he worked primarily on clinical research studies in adult affective disorders, sleep medicine, and addiction.
Scott has authored or co-authored three book chapters and several dozen publications in statistical and medical journals on topics including Bayesian and adaptive clinical trial design, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is currently editor of the journal Pharmaceutical Statistics. He holds a PhD in biostatistics from Pitt, and MA in mathematics from Washington University in St. Louis, and a BA in liberal arts from Sarah Lawrence College.