*Applications will be reviewed on a rolling-basis.

A research opportunity is available in the Office of the Center Director (OCD)/ Controlled Substance Staff (CSS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

This project will analyze outcome measures from human abuse potential (HAP) studies and compare those to real-world abuse. Project will help to enhance scientific approaches that aid in developing new drugs or evaluating their pre-market safety and efficacy.

Under the guidance of a mentor the participant will collaborate with other groups within CDER. The participant will gain a comprehensive understanding of human abuse potential study design, statistics, and review. In combination with the Office of Computational Science (OCS), the participant will learn to develop a searchable database of human abuse potential (HAP) studies to use and compare data across different endpoints. Analysis of this data will be conducted under the supervision of pharmacologists and medical officers in CSS and statisticians in the office of biometrics (DB VI).

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.

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2021-0613) in your email.