Associate Director, Biostatistics (4)

CSL Behring

Multiple Locations
**
Statistical strategy for clinical trials
Regulatory submission expertise
Clinical development program leadership
** CSL Behring is seeking an Associate Director of Biostatistics to lead statistical contributions to clinical development programs. The ideal candidate will possess significant experience in drug development and regulatory submissions and will play a key role in defining statistical strategies and methodologies. **

Job Summary

  • Lead the full scope of statistical contribution to a clinical development program, defining statistical strategies for trials and regulatory submissions.
  • Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
  • Represent Biostatistics in interactions with regulatory authorities and manage outsourcing operations for timely and quality deliverables.

Matching Summary

Match Score: 75

** CSL Behring is seeking an Associate Director of Biostatistics to lead statistical contributions to clinical development programs. The ideal candidate will possess significant experience in drug development and regulatory submissions and will play a key role in defining statistical strategies and methodologies. **

Skills & Requirements

Must-have

  • Statistical strategy for clinical trials
  • Regulatory submission expertise
  • Clinical development program leadership
  • Advanced statistical methodologies
  • SAS and/or R proficiency

Nice-to-have

  • Innovation track record
  • Interaction with regulatory authorities
  • CRO management experience

Key Requirements

  • PhD with 8 years or MS with 11 years of experience in drug development
  • Statistical leadership at compound/indication level
  • Experience in regulatory submissions
  • Familiarity with regulatory guidance

Work Rights

Not specified

Tailored Resume

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