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A complete application consists of:

• An application
• Transcripts –
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• One educational or professional recommendation

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.

A research opportunity is currently available in the Office of Study Integrity and Surveillance (OSIS), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) located in Silver Spring, Maryland. CDER performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This research covers more than just medicines.

The aim of this project is to establish a statistical basis to ensure that the bioequivalence data submitted in Abbreviated New Drug Applications (ANDAs) are sound and comparable to the known clinical pharmacology of the drug. The project will compile historical pharmacokinetic data for select drugs and evaluate drug concentrations and pharmacokinetic parameters based on subject level data.

Under the guidance of the mentor, the participant will learn the principles, objectives, and conduct of bioequivalence studies submitted in support of ANDAs. The participant will also learn how CDER Offices evaluate bioequivalence studies to ensure that the data supporting generic drug approvals are reliable. The participant will learn and utilize statistical methodologies developed within the Agency to evaluate pharmacokinetic data across multiple ANDA applications. Through this project, the participant will contribute to the overall understanding of drug concentration profiles originating from bioequivalence studies.

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 full-time 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 on location 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 Ethics Requirements If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.

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.

Preferred skills/ knowledge:

• Good understanding of bioequivalence studies
• Demonstrated analytical skills
• Strong Familiarity with Excel
• Data handling skills using R or Python
• Familiarity with R-Shiny

• Degree: Master's Degree or Doctoral Degree received within the last 60 months or anticipated to be received by 7/31/2023 11:59:59 PM.
• Discipline(s):
  • Computer, Information, and Data Sciences
  • Life Health and Medical Sciences
  • Other Physical Sciences

I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)

AND

I have read the FDA Ethics Requirements.