Associate Director, Biostatistics (2)

CSL Behring

Multiple Locations, ,
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Statistical strategy for clinical trials
Lead statistical contribution to development programs
Regulatory submissions statistical expertise
** CSL Behring is seeking an Associate Director of Biostatistics to lead statistical contributions to clinical development programs across various therapeutic areas. The role emphasizes strategic statistical planning, regulatory interactions, and collaboration with cross-functional teams to ensure the successful execution of clinical trials. **

Job Summary

  • Lead the full scope of statistical contribution to a clinical development program, defining statistical strategies and ensuring appropriate methodologies.
  • Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria.
  • 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 across various therapeutic areas. The role emphasizes strategic statistical planning, regulatory interactions, and collaboration with cross-functional teams to ensure the successful execution of clinical trials. **

Skills & Requirements

Must-have

  • Statistical strategy for clinical trials
  • Lead statistical contribution to development programs
  • Regulatory submissions statistical expertise
  • SAS and/or R proficiency

Nice-to-have

  • Track record of innovation
  • Interactions with major regulatory authorities
  • Experience with CRO management

Key Requirements

  • PhD with 8 years or MS with 11 years of experience in drug development
  • Experience providing statistical leadership at compound/indication level
  • Leading roles in regulatory submissions
  • Experience with CROs or managing internal deliveries preferred

Work Rights

Not specified

Tailored Resume

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