A complete application consists of:
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of New Drugs/Office of Drug Evaluation IV, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.
The proposed project is aimed at exploring quantitative methods using existing data obtained from adult and pediatric clinical trials for Bayesian-based pediatric extrapolation. This project will use a systematic approach to support extrapolation in pediatric product development. The information obtained will be used to create a framework that could be used in other disease areas to provide "best practices" for evaluation of elements that can be used to predict disease and response similarity between adults and pediatric patients.
Under the guidance of a mentor the participant will gain experience related to approaches used to generate analysis datasets, methodologies for data analyses, and regulatory considerations when extrapolating adult data to pediatrics. The participant will have an opportunity to create a framework that could be used to apply Bayesian methods to other disease states.
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:
The qualified candidate should be currently pursuing or have received a bachelor's, master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
Familiarity with drug development principles is desired.