FDA Research Fellowship - Characterizing Use of Real-World Evidence to Support Effectiveness for New Indications

About the role

The Center for Drug Evaluation and Research (CDER) within the U.S. Food and Drug Administration (FDA) is seeking a researcher to conduct a systematic review of internal FDA approval documentation for new approvals. The project involves extracting key characteristics related to approval context, regulatory pathways, intended versus actual use of real-world evidence (RWE), and FDA review findings.

Responsibilities

• Conduct a comprehensive systematic review of internal FDA approval documentation, including clinical, epidemiological, and statistical reviews, advisory committee materials, and labeling.
• Extract key characteristics related to approval context, regulatory pathway, intended versus actual use of RWE, and FDA review findings.
• Develop at least 10 training-ready case studies across therapeutic areas focused on the use of RWE in demonstrations of effectiveness for newly approved drugs and biologics.
• Create a standardized case study template and an internal data repository to enable access to and dissemination of findings.
• Engage with subject matter experts and reviewers across other FDA Centers to explore how findings, case studies, and best practices developed through this project may be adapted or extended to support RWE use in regulatory decision-making across the Agency.
• Translate synthesized findings into actionable best practices that support the consistent and appropriate use of RWD and RWE across Divisions within CDER for new approvals.
• Communicate key findings and recommendations through the development of standardized case study templates, an internal data repository, peer-reviewed publications, conference presentations, and strategic reports.

Requirements

The candidate should have received or currently be pursuing a doctoral degree (PhD or equivalent) in one of the relevant fields (epidemiology, data science, mathematics, statistics). Degree must have been received within the past five years or is anticipated to be completed by August 31, 2027. Candidates with a clinical doctorate (e.g., PharmD, MD) or equivalent and relevant experience will also be considered.

Qualifications

• Doctoral degree (PhD or equivalent) in relevant field (epidemiology, data science, mathematics, statistics).
• Anticipated completion of degree by August 31, 2027.
• Relevant experience in data science, epidemiology, or related field.

Skills

Strong analytical and research skills, proficiency in data analysis software, and experience with systematic reviews are preferred.

Benefits

Monthly stipend commensurate with educational level and experience.

Pay

Salary range is determined based on the candidate's qualifications and experience.

Schedule

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