The Associate Director of Biostatistics position at CSL Seqirus involves leading statistical contributions for clinical development programs, ensuring the delivery of high-quality statistical analyses for trials and regulatory submissions. The ideal candidate should possess advanced statistical expertise, significant experience in drug development, and familiarity with regulatory interactions
Job Summary
Lead the full scope of statistical contribution to a clinical development program, defining statistical strategies for trials and regulatory submissions.
Influence clinical development plans, collaborate with cross-functional teams, and represent Biostatistics in interactions with regulatory authorities.
Manage outsourcing operations or internal statistical programmers, ensuring timely and quality delivery of statistical deliverables.
Matching Summary
Match Score: 85
The Associate Director of Biostatistics position at CSL Seqirus involves leading statistical contributions for clinical development programs, ensuring the delivery of high-quality statistical analyses for trials and regulatory submissions. The ideal candidate should possess advanced statistical expertise, significant experience in drug development, and familiarity with regulatory interactions.
Skills & Requirements
Must-have
Statistical strategy for clinical trials
Regulatory submission support
Cross-functional team collaboration
SAS and/or R proficiency
Advanced statistical methodologies
Nice-to-have
Innovation in statistical methodology
Experience with CROs
Track record of innovation
Key Requirements
PhD with 8 years or MS with 11 years of experience in drug development
Statistical leadership at compound/indication level
Leading roles in regulatory submissions
Experience with major regulatory authorities preferred
Experience with CROs or managing internal deliveries preferred