Associate Director, Biostatistics

CSL Ltd

Multiple Locations
**
Statistical strategy for clinical trials
Regulatory submission leadership
Advanced statistical methodologies
** CSL Ltd is seeking an Associate Director of Biostatistics to lead statistical contributions to clinical development programs, responsible for the design and analysis of clinical trials and regulatory submissions. The ideal candidate will have significant experience in drug development, statistical methodology, and regulatory interactions, coupled with strong leadership and communication skills. **

Job Summary

  • The Associate Director, Biostatistics leads the full scope of statistical contribution to a clinical development program, providing statistical strategies for clinical trials and regulatory submissions.
  • Responsibilities include defining statistical strategy, ensuring appropriate methodologies, influencing clinical development plans, and representing Biostatistics in regulatory interactions.
  • CSL offers a culture of inclusion and belonging, aiming to help patients around the world lead better, healthier lives.

Matching Summary

Match Score: 75

** CSL Ltd is seeking an Associate Director of Biostatistics to lead statistical contributions to clinical development programs, responsible for the design and analysis of clinical trials and regulatory submissions. The ideal candidate will have significant experience in drug development, statistical methodology, and regulatory interactions, coupled with strong leadership and communication skills. **

Skills & Requirements

Must-have

  • Statistical strategy for clinical trials
  • Regulatory submission leadership
  • Advanced statistical methodologies
  • SAS and/or R proficiency
  • Cross-functional team collaboration

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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