ORISE Fellowship Opportunity at the FDA: Use of Synthetic Control Arm

The Division of Pediatric and Maternal Health at the FDA in collaboration with the Oncology Center of Excellence is seeking a fellow who is interested in working on a regulatory science project. Single arm, uncontrolled studies are used in approximately 25% of pediatric drug development programs and 63% of rare disease trials. Single arm trials are often difficult to interpret. This project proposes that patient-level matching approaches like propensity scores can be used with historical clinical trial data to create a synthetic control arm to improve context for the interpretation of single arm trials. The participant will gain extensive knowledge on methodological approaches used with historical clinical trial data to create a synthetic control arm. In addition, the participant will gain experience in review of methodological features of studies, data curation and database building, data analysis, dissemination of results (presentations, publications), etc. Opportunities are available for current students in a Ph.D. or other professional doctorate program and graduates with a doctoral degree in statistics, pharmacometrics, etc. Interested applicants should apply directly using the link below: https://www.zintellect.com/Opportunity/Details/FDA-CDER-2020-0556 Lily Mulugeta, PharmD [email protected]<mailto:[email protected]> Associate Director, Policy and Research Division of Pediatric and Maternal Health Office of New Drugs, CDER, FDA