Director Biostatistics - Hematology

CSL Ltd

Multiple Locations
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Statistical strategy and methodology
Clinical development plans and study design
Data analysis, interpretation, and reporting
** CSL Ltd is seeking a Director of Biostatistics to lead statistical contributions in clinical development, focusing on hematology. The role requires extensive experience in clinical trials and collaboration with regulatory authorities, while offering a hybrid work environment and a commitment to diversity and inclusion. **

Job Summary

  • The Director, Biostatistics, leads the full scope of statistical contribution to a clinical development program, including life cycle management.
  • Define the statistical strategy and ensure appropriate statistical methodologies applied to the clinical development plan, study design and data analysis for clinical trials, and regulatory submissions.
  • Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA), which includes leading written responses to regulatory questions and attending regulatory meetings.

Matching Summary

Match Score: 75

** CSL Ltd is seeking a Director of Biostatistics to lead statistical contributions in clinical development, focusing on hematology. The role requires extensive experience in clinical trials and collaboration with regulatory authorities, while offering a hybrid work environment and a commitment to diversity and inclusion. **

Skills & Requirements

Must-have

  • Statistical strategy and methodology
  • Clinical development plans and study design
  • Data analysis, interpretation, and reporting
  • Regulatory interactions and submissions
  • Cross-functional team collaboration

Nice-to-have

  • Maximizing probability of program success
  • Leading through influence in a matrixed environment
  • Communicating results effectively

Key Requirements

  • PhD or MS/MA in statistics or related field
  • 10+ years of experience in clinical development
  • Demonstrated leadership in statistical contributions
  • Experience partnering with cross-functional teams
  • Experience interacting with health authorities
  • Experience managing external partners (CROs, consultants)
  • Experience with CDISC standards
  • Experience with programming oversight
  • Experience with statistical operations

Work Rights

Not specified

Tailored Resume

Cover Letter