Employer: Oak Ridge Institute for Science and Education
*Applications will be reviewed on a rolling-basis.A research opportunity is currently available in the Office of Translational Sciences / Office of Biostatistics (OB) at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland. During the process of discussing the clinical development of drugs for the treatment or prevention of COVID-19, questions have arisen regarding appropriate statistical methodology to be used in the evaluation of data produced from such development programs. The answers to these questions can impact statistical analysis plans outlining the prespecified analytical methods to be utilized in the analyses of data from these COVID-19 development programs and study protocols describing the design and conduct of these studies. The project aims to address several of these statistical questions, which include selecting appropriate missing data imputation models and methods for analyzing time-to-event endpoints.Under the guidance of the mentor the participant will gain insight regarding the regulatory process for evaluating the safety and efficacy of investigational drugs, as well as regulatory challenges that arise during the statistical evaluation of data collected for the purpose of addressing public health emergencies. Furthermore, the participant will gain experience conducting simulation studies and preparing reports/presentations summarizing the research results.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 three months, 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.If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2021-0620) in your email.