Senior Director, Biostatistics, Europe

Revolution Medicines

Remote
**
Statistical leadership for eu access strategies
Biostatistics sme for quantitative sciences
Support ema, mhra, swissmedic regulatory submissions
** Revolution Medicines is seeking a Senior Director of Biostatistics to lead statistical efforts for clinical programs, focusing on European market access and regulatory submissions. The position requires extensive experience in biostatistics within the biotech or pharmaceutical industry, particularly in oncology and European regulatory environments. **

Job Summary

  • Serve as the statistical lead for European access strategies, ensuring alignment between Global Clinical Development, European regulatory (EMA, MHRA, Swissmedic...) and regional/local Market Access needs to support successful European launches.
  • Partner with the development statistical lead, provide statistical support for EU regulatory interactions, including EMA Scientific Advice, MAA, Type II variations, and post-authorization commitments.
  • Contribute to the global statistical strategy, ensuring study designs and endpoints satisfy both regulatory approval and reimbursement dossier standards in Europe, proactively addressing diverse data requirements for payers across different European jurisdictions.

Matching Summary

Match Score: 75

** Revolution Medicines is seeking a Senior Director of Biostatistics to lead statistical efforts for clinical programs, focusing on European market access and regulatory submissions. The position requires extensive experience in biostatistics within the biotech or pharmaceutical industry, particularly in oncology and European regulatory environments. **

Skills & Requirements

Must-have

  • Statistical leadership for EU access strategies
  • Biostatistics SME for Quantitative Sciences
  • Support EMA, MHRA, Swissmedic regulatory submissions
  • Proficiency in SAS and/or R
  • Experience in oncology trials

Nice-to-have

  • Experience with HTA submissions
  • Engaging with European scientific advice
  • Deep understanding of EMA landscape
  • Active participation in NDA/BLA filing

Key Requirements

  • Ph.D. or M.S. with 10+ years (Ph.D.) or 15+ years (M.S.) experience
  • Solid knowledge in ICH and regulatory requirements
  • Advanced methodological and technical skills
  • Strong problem solving and critical thinking abilities

Work Rights

Not specified

Tailored Resume

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