Shanti Gomatam is a Mathematical Statistician in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). She joined the FDA in 2003 and her 20+ years of experience include about a decade each of experience in CDER and the Center for Devices and Radiological Health (CDRH). Her work at the FDA spans multiple areas including quantitative safety and efficacy of drugs/biologics across a variety of therapeutic areas, and therapeutic and diagnostic devices for a range of uses. These have involved the review of high-profile submissions including cardiovascular outcomes trials and other safety trials in CDER and cardiovascular devices and digital pathology in CDRH, participation in guidance writing, directing research for ORISE interns, teaching, publication, and presentations at internal and external venues.
Prior to joining the FDA she was a Fellow at the National Institute of Statistical Sciences, an Assistant Professor in the Department of Mathematics at the University of South Florida, and a Postdoctoral Associate at the University of Florida. She holds Ph.D. and M.S. degrees in Statistics from Florida State University and an M.Sc. from the University of Bombay.