Expertise in cdisc standards and programming oversight
The Director leads the full scope of statistical contribution to a clinical development program including life cycle management for hematology therapies
Job Summary
The Director leads the full scope of statistical contribution to a clinical development program including life cycle management for hematology therapies.
This role requires representing Biostatistics in interactions with regulatory authorities such as the FDA, EMA, and PMDA.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives using innovative technologies across multiple therapeutic areas.
Matching Summary
The Director leads the full scope of statistical contribution to a clinical development program including life cycle management for hematology therapies.
Skills & Requirements
Must-have
10+ years clinical development experience
PhD or MS in statistics required
Expertise in CDISC standards and programming oversight
Experience managing external CRO partners
Strong knowledge of regulatory submission processes
Nice-to-have
Strategic and analytical mindset
Ability to lead through influence in matrixed environment
Excellent communication and interpersonal skills
Experience with integrated analysis delivery
Key Requirements
PhD or MS/MA in statistics or related field
10+ years of experience in pharmaceutical industry
Demonstrated leadership in statistical contributions to regulatory submissions