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

Landscape Analysis

You will be a part of the following activities:

• 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Evaluate the CDER/CBER draft guidance and stakeholder commentaries. Conduct systematic literature reviews to identify novel Bayesian methodologies aligned with the draft guidance that demonstrate potential utility for medical device regulation.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

• 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@fda.hhs.gov).

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.

Program Information

The 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.

Background Investigation

A 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.

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Qualification Requirements

• I am a U.S. Citizen, or I have lived in the United States for at least 36 out of the past 60 months.
• I have read the FDA Ethics Requirements.

Preferred Skills

• Bayesian statistics, clinical trial design, and simulation methodology.
• Strong quantitative training.
• Degree: Master's Degree.
• Discipline(s): Mathematics and Statistics (11)