*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of New Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.
This project in the Office of New Drugs focuses on safety analyses and research related to the conduct of safety data analyses to support regulatory review. Under the guidance of a mentor the participant may be involved in:
- Learning fundamentals of regulatory clinical trial design focused on safety assessment components, protocol structure and content, specification of safety analytic plans in statistical analysis plan documents, and data collection (eCRF structures and limitations)
- Gaining a detailed understanding of CDISC format and structure (both SDTM and ADaM) for safety data from clinical trials
- Analyzing safety data from clinical trials using standard and newly developed tools, and source program code in R, Python, SAS, and Julia
- Using/applying learned knowledge and programming skills to assess specific or common safety signals (e.g., drug-induced liver injury)
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.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:
- Non-employee nature of the ORISE appointment;
- Prohibition on ORISE Fellows performing inherently governmental functions;
- Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
- The fact that research materials and laboratory notebooks are the property of the FDA;
- ORISE fellow’s obligation to protect and not to further disclose or use non-public information.
If you have questions, send an email to ORISE.FDA.CDER@orau.org.