*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available in the Office of New Drugs / Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
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.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
The qualified candidate should be currently pursuing or have received a doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0556) in your email.