Senior Director, Biostatistics

Sarepta Therapeutics

United States
Not specified; not specified; competitive compensa...
Hybrid
Ph.d. in statistics or related discipline
11+ years pharmaceutical industry experience
Leading ndas, maas regulatory submissions
This role leads a biometrics team to advance transformative precision genetic medicines in Duchenne muscular dystrophy and other diseases

Job Summary

  • This role leads a biometrics team to advance transformative precision genetic medicines in Duchenne muscular dystrophy and other diseases.
  • The successful candidate will drive rigorous regulatory-grade deliverables while fostering a culture of rapid, hands-on data exploration.
  • Sarepta offers comprehensive benefits supporting physical wellness, financial wellness, and caregiver support within a hybrid work environment.

Matching Summary

This role leads a biometrics team to advance transformative precision genetic medicines in Duchenne muscular dystrophy and other diseases.

Salary

Not specified; Not specified; Competitive compensation package mentioned

Skills & Requirements

Must-have

  • Ph.D. in statistics or related discipline
  • 11+ years pharmaceutical industry experience
  • Leading NDAs, MAAs regulatory submissions
  • Proficient in SAS and R statistical programming
  • Experience with FDA EMA ICH regulations

Nice-to-have

  • Experience in rare disease or gene therapy
  • Knowledge of Bayesian approaches
  • Familiarity with real-world data methods
  • Enthusiasm for modern AI tools adoption
  • Experience with trial design software EAST

Key Requirements

  • Ph.D. in statistics with 11+ years experience
  • Master's Degree with 13+ years experience
  • Must be authorized to work in the U.S.
  • Proven track record leading clinical development programs
  • Ability to manage CRO relationships effectively

Work Rights

Must be authorized to work in the U.S.

Tailored Resume

Cover Letter