Associate Director, Biostatistics (4)

CSL Behring

Multiple Locations
**
Statistical strategy for clinical trials
Regulatory submission deliverables
Advanced statistical methodologies
** CSL Behring is seeking an Associate Director of Biostatistics to lead statistical contributions to clinical development programs. The position requires extensive experience in drug development, statistical methodologies, and regulatory submissions. **

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.
  • Represent Biostatistics in interactions with regulatory authorities and manage outsourcing operations or internal statistical programmers.

Matching Summary

Match Score: 75

** CSL Behring is seeking an Associate Director of Biostatistics to lead statistical contributions to clinical development programs. The position requires extensive experience in drug development, statistical methodologies, and regulatory submissions. **

Skills & Requirements

Must-have

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

Nice-to-have

  • Innovative study design
  • Interaction with regulatory authorities
  • Track record of innovation
  • CDISC and data standards

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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