Regulatory Bayesian Methods Research Fellowship

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 27,900 - 44,640; Full time

Job summary

The Oak Ridge Institute for Science and Education (ORISE) invites you to join a FDA, Center for Devices and Radiological Health (CDRH) fellowship in Silver Spring, MD. You will contribute to Bayesian regulatory science by reviewing guidance, conducting literature reviews, and evaluating novel Bayesian methods with simulations.

Your work focuses on prior-data conflict, adaptive borrowing, and interim decision metrics across various endpoints, under mentorship, for a time-limited one-year

Qualifications

• Master's degree in Mathematics or Statistics or related field.
• Strong quantitative training and data analysis skills.
• Experience with Bayesian methods is a plus.

Responsibilities

• Survey Bayesian designs used in CDRH device approvals.
• Evaluate draft guidance and perform literature reviews.
• Conduct simulations to assess Bayes-based methods.
• Examine prior-data conflicts and adaptive borrowing concepts.
• Assess PPoS-based interim decision metrics through simulations.

Skills

Bayesian statistics

Clinical trial design

Simulation methodology

Quantitative analysis

Education

Master's degree in Mathematics and Statistics

Job description

The Oak Ridge Institute for Science and Education (ORISE) invites you to join a FDA, Center for Devices and Radiological Health (CDRH) fellowship in Silver Spring, MD. You will contribute to Bayesian regulatory science by reviewing guidance, conducting literature reviews, and evaluating novel Bayesian methods with simulations.

Your work focuses on prior-data conflict, adaptive borrowing, and interim decision metrics across various endpoints, under mentorship, for a time-limited one-year