Rima Izem is an Associate Professor of Pediatrics at Children’s National Research Institute and the George Washington University, since December 2018. At Children’s National, she supports different aspects of clinical research as they relate to study design and statistical analyses of clinical and epidemiological studies in the pediatric population. Her research interests include study design in rare diseases, causal inference, and signal detection in large electronic healthcare databases.
Prior to joining Children’s National, she was a senior statistician at the Food and Drug Administration (FDA) with expertise in design and analysis of studies supporting safety or effectiveness of medical products. She was a leader in translating statistical methods for use for regulatory purposes, whether the data originated from primary data sources such as surveys and clinical trials, or originated from secondary data sources such as claims and electronic healthcare records in Sentinel Distributed System. For FDA-led or industry-led studies, she collaborated or provided input on statistical methods development, their use, and communication of their results in presentations and publications. She managed a team of 4-5 PhD level statisticians in regulatory review and collaborated on every project with a team of scientists including clinicians, epidemiologists, psychologists and microbiologists to inform decisions in medical product development. Because of her expertise, she co-wrote several guidance documents with advice on design and analysis of studies supporting medical product development. Her experience in drug review spans pre-market and post-market development across a wide range of therapeutic areas: cardiovascular, anti-infective, ophthalmic, reproductive health, analgesia and addiction and antiviral.
Prior to joining FDA, Dr. Izem was an Assistant Professor at the Department of Statistics at Harvard University for 4 years where she taught and developed methods for high dimensional data from biology, astrophysics, economics or geographic information systems. She received her PhD in Statistics from the University of North Carolina at Chapel Hill.