Director Biostatistics

Seqirus

Hybrid
10+ years clinical development experience
Phd or ms/ma in statistics
Regulatory submission leadership
The Director leads the full scope of statistical contribution to a clinical development program including life cycle management

Job Summary

  • The Director leads the full scope of statistical contribution to a clinical development program including life cycle management.
  • This role requires representing Biostatistics in interactions with regulatory authorities such as the FDA, EMA, and PMDA.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies.

Matching Summary

The Director leads the full scope of statistical contribution to a clinical development program including life cycle management.

Skills & Requirements

Must-have

  • 10+ years clinical development experience
  • PhD or MS/MA in statistics
  • Regulatory submission leadership
  • CDISC standards expertise
  • Cross-functional team collaboration

Nice-to-have

  • Experience managing external CRO partners
  • Strong communication skills for presentations
  • Ability to work in a matrixed environment
  • Strategic analytical mindset
  • Influence without authority

Key Requirements

  • 10+ years pharmaceutical industry experience
  • PhD or Master's degree in Statistics
  • Leadership in regulatory submissions
  • Experience with CDISC standards

Work Rights

Not specified

Tailored Resume

Cover Letter