FDA Research - Assessment of Bayesian Statistical Methods Applied in Regulatory Contexts

FDA-CDRH-

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDRH-

Description

• Applications will be reviewed on a rolling-basis.

FDA Office and

Location:

A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), located in Silver Spring, Maryland.

The mission of CDRH is to protect and promote public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH provides consumers, patients, caregivers, and providers with understandable and accessible science-based information about products. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

Research Project:
You will be a part of the following activities:

• Landscape Analysis:
  Survey Bayesian designs used in CDRH device approvals to identify successes, limitations, and recurring challenges.
• Reviewing Guidance and Literature Review:
  Evaluate the CDER/CBER draft guidance and stakeholder commentaries. Conduct systematic literature reviews to identify novel Bayesian methodologies aligned with the draft guidance that demonstrate potential utility for medical device regulation.
• Methodological Evaluation via Simulation:
  Assess novel approaches—such as Bayes factors and Calibrated Bayes—through simulation studies to evaluate their performance and suitability for regulatory decision-making.
• Assessment of Prior Data Conflict:
  Examine historical challenges related to prior-data conflict in Bayesian designs and evaluate whether newer methods (e.g., adaptive borrowing or discounting) mitigate these issues.
• Evaluation of Interim Decision Metrics:
  Conduct simulation studies to assess uncertainty and operating characteristics of PPoS-based interim decision rules across various endpoint types (binary, continuous, time-to-event), modeling assumptions, and data-borrowing strategies.

Learning Objectives:
Under the guidance of a mentor, you will be a part of a time-sensitive, high-impact regulatory science initiative while gaining:

• Direct experience with FDA guidance interpretation and impact assessment
• Insight into regulatory applications of Bayesian methods in medical devices
• Hands-on experience evaluating novel statistical methodologies
• Mentorship and skills that help you develop your future goals

Mentor:
The mentor for this opportunity is Rajesh Nair (Rajesh.Nair.gov). 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, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

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 participant will receive a monthly stipend commensurate with educational level and experience. 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  can complete a…