The Director leads the full scope of statistical contribution to a clinical development program, ensuring statistical excellence from planning to regulatory submissions
Job Summary
The Director leads the full scope of statistical contribution to a clinical development program, ensuring statistical excellence from planning to regulatory submissions.
This role requires representing Biostatistics in interactions with major regulatory authorities such as the FDA, EMA, and PMDA.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies in immunology and hematology.
Matching Summary
The Director leads the full scope of statistical contribution to a clinical development program, ensuring statistical excellence from planning to regulatory submissions.
Skills & Requirements
Must-have
10+ years clinical development experience
PhD or MS/MA in statistics
Regulatory submission expertise
CDISC standards knowledge
CRO management experience
Nice-to-have
Strong cross-functional collaboration skills
Experience with plasma fractionation platforms
Ability to lead through influence in matrixed environment
Key Requirements
10+ years pharmaceutical/biotech industry experience
PhD or MS/MA degree required
Demonstrated leadership in statistical contributions