Director Biostatistics

CSL Behring

Hybrid (3 in-office days per week)
10+ years clinical development experience
Phd or ms in statistics
Regulatory submission leadership
CSL Behring is seeking a Director of Biostatistics to lead statistical contributions to clinical development programs, ensuring robust data analysis and regulatory compliance. The role emphasizes collaboration with cross-functional teams and requires extensive experience in clinical development within the pharmaceutical or biotechnology industry

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

Match Score: 85

CSL Behring is seeking a Director of Biostatistics to lead statistical contributions to clinical development programs, ensuring robust data analysis and regulatory compliance. The role emphasizes collaboration with cross-functional teams and requires extensive experience in clinical development within the pharmaceutical or biotechnology industry.

Skills & Requirements

Must-have

  • 10+ years clinical development experience
  • PhD or MS in statistics
  • Regulatory submission leadership
  • CDISC standards expertise
  • CRO management experience

Nice-to-have

  • Strong cross-functional collaboration skills
  • Experience with plasma fractionation technologies
  • Ability to work in matrixed environment
  • Excellent communication and interpersonal skills

Key Requirements

  • 10+ years pharmaceutical/biotech experience
  • PhD or MS/MA in statistics
  • Leadership in regulatory submissions
  • Experience managing external partners

Work Rights

Not specified

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