FDA Leveraging Existing Data for Pediatric Extrapolation

Organization
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CDER-2019-0470
How to Apply

A complete application consists of:      

  • An application
  • Transcripts – Click here for detailed information about acceptable transcripts
  • A current resume/CV, including academic history, employment history, relevant experiences, and publication list
  • One educational or professional recommendation. Your application will be considered incomplete, and will not be reviewed until one recommendation is submitted.

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.

Application Deadline
3/31/2020 3:00:00 PM Eastern Time Zone
Description

*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:

  • 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.
Qualifications

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.

Eligibility Requirements
  • Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree received within the last 60 months or currently pursuing.
  • Discipline(s):
    • Computer Sciences (1 )
    • Engineering (1 )
    • Life Health and Medical Sciences (47 )
    • Mathematics and Statistics (11 )