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The FDA-OCE-ASA Oncology Educational Fellowship is a collaborative endeavor of the Food and Drug Administration’s Oncology Center of Excellence (FDA-OCE), the American Statistical Association (ASA), and the ASA’s Biopharmaceutical Statistics Section (BIOP). The program will provide the opportunity for statistics and biostatistics graduate students and post-doctoral fellows to learn about oncology drug development and regulatory policy.

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Tentative Workshop Topics

  • Clinical Trials in Oncology
  • Earlier/Intermediate Endpoints
  • Multiplicity in Oncology Trials
  • Subgroup Analyses
  • Progression-free survival
  • Overall survival
  • Adaptive and Bayesian Designs in Oncology
  • RWE, External Controls, Observational Studies
  • Role of Statisticians in data monitoring committees
  • Vaccine and Cell Therapy Clinical Trials
  • Emerging Statistical Issues in Oncology
  • CID / Careers and Role of Statisticians at FDA

Overview

There is no cost to participate.

The program is open to:

  • PhD students in biostatistics or statistics programs who have passed their program’s qualifying examinations 
  • Current post-doctoral fellows in biostatistics or statistics with a specific interest in oncology drug development.
  • All participants must have completed coursework in clinical trials design and in survival analysis.

Logistics:

  • 8 three-hour online sessions
  • program begins in October 2024
  • program ends in May 2025

Application requires:

  • Statement of interest
  • Current CV
  • one letter of reference

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Review of applications will begin August 15, 2024

Submit your application materials here.

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