FDA Fellowship - Office of Pharmaceutical Quality (OPQ) Initiative - Data Analysis

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 60,000 - 70,000; Full time

Job summary

Oak Ridge Institute for Science and Education offers a research opportunity with FDA CDER in Silver Spring, MD. The position focuses on analyzing assignment data, improving data validation, and enhancing the assignment tool algorithm. The role provides a monthly stipend and is a full-time, one-year appointment with potential renewal.

Applicants must have a Master’s degree in a relevant field within the last five years and be a U.S. citizen or LPR.

Qualifications

• Master's degree in a relevant field, received within the last five years.
• Eligibility requires U.S. citizenship or lawful permanent resident status.

Responsibilities

• Analyze assignment data from December 2025 to present to identify workload distribution patterns.
• Refine the algorithm using mathematical modeling, programming, and integrated data systems to improve performance.
• Support data validation and contribute to OPQ business processes and databases.

Education

Master's Degree in a relevant field

Job description

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDER-2026-0185

Application Deadline

12/4/2026 3:00:00 PM Eastern Time Zone

Description

• Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and Research (CDER), located at Silver Spring, Maryland.

The Center for Drug Evaluation and Research (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 U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. These efforts cover more than just medicines.

Research Project: This project supports the Office of Pharmaceutical Quality (OPQ) Assignment Tool initiative by improving data validation and algorithm performance. You will analyze assignment data from December 2025 to the present to identify workload distribution patterns and refine the algorithm using mathematical modeling, programming, and integrated data systems. Project outcomes will enhance assignment allocation and improve the efficiency and consistency of pharmaceutical quality assessments.

Learning Objectives: You will gain experience in data analysis, algorithm development, and the use of statistical software and data warehouses, while using pharmaceutical quality submission data. You will also develop an understanding of OPQ business processes, databases, and the regulatory assessment of drug applications.

Mentor: The mentor for this opportunity is Nancy Tian ([e-mail]). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: 2026. Start date is flexible and will depend on a variety of factors.

Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of Participation: The appointment is full time.

Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience.

Citizenship Requirements: This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only.

In addition, proof of health insurance is required for participation in this program. 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.

If you have questions, send an email to [e-mail]. Please include the reference code for this opportunity in your email.

Qualifications

The qualified candidate should have received a master's degree in the one of the relevant fields. Degree must have ben received within the past five years.

Point of Contact

Ashley

Eligibility Requirements

• Citizenship: LPR or U.S. Citizen
• Degree: Master's Degree received within the last 60 month(s).
• Discipline(s):
  • Chemistry and Materials Sciences
  • Analytical Chemistry
  • Bio-inorganic Chemistry
  • Bio-organic Chemistry
  • Biophysical Chemistry
  • Chemistry (General)
  • Environmental Chemistry
  • Inorganic Chemistry
  • Materials Sciences
  • Organic Chemistry
  • Physical Chemistry
  • Polymer Chemistry
  • Theoretical Chemistry
• Communications and Graphics Design (2)
• Computer, Information, and Data Sciences (17)
• Earth and Geosciences (21)
• Engineering (29)
• Environmental and Marine Sciences (14)
• Life Health and Medical Sciences (51)
• Mathematics and Statistics (11)
• Physics (16)
• Social and Behavioral Sciences (29)

Affirmation

I am a U.S. citizen, or 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.)