Director, Biostatistics

Fulcrumtherapeutics

Cambridge, MA, United States
Base: $225,000 - $250,000 usd; bonus/equity: not s...
On-site
Phd in biostatistics or statistics
8 years clinical biostatistics experience
Innovative study design methodologies
Fulcrum Therapeutics is seeking a Director of Biostatistics to lead statistical activities for clinical development programs, ensuring compliance with regulatory standards. The ideal candidate will have significant biostatistics experience and a strong understanding of innovative methodologies, with proficiency in statistical software

Job Summary

  • The role serves as a hands-on statistics subject matter expert for clinical development programs at Fulcrum Therapeutics.
  • Candidates will provide strategic statistical input on study design, protocol development, and regulatory agency interactions.
  • The position requires ensuring high-quality delivery of statistical analysis plans while overseeing activities in outsourced clinical trials.

Matching Summary

Match Score: 85

Fulcrum Therapeutics is seeking a Director of Biostatistics to lead statistical activities for clinical development programs, ensuring compliance with regulatory standards. The ideal candidate will have significant biostatistics experience and a strong understanding of innovative methodologies, with proficiency in statistical software.

Salary

Base: $225,000 - $250,000 USD; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • PhD in Biostatistics or Statistics
  • 8 years clinical biostatistics experience
  • Innovative study design methodologies
  • SAS and R statistical software proficiency
  • Regulatory requirements knowledge GCP ICH CDISC

Nice-to-have

  • Regulatory interaction and submission experience
  • Oversight of outsourced clinical trials
  • Cross-functional collaboration skills
  • Publication support experience

Key Requirements

  • Ph.D. in Biostatistics with 8+ years experience OR Master's with 10+ years
  • Extensive knowledge of GCP, ICH, and CDISC regulatory standards
  • Proficiency in SAS, R, and simulation tools

Work Rights

Not specified

Tailored Resume

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