CSL Behring is seeking a Director of Biostatistics for their hematology division, responsible for overseeing statistical contributions to clinical development programs and regulatory interactions. The role requires extensive experience in clinical development and strong leadership skills, with a focus on collaboration and communication
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: 85
CSL Behring is seeking a Director of Biostatistics for their hematology division, responsible for overseeing statistical contributions to clinical development programs and regulatory interactions. The role requires extensive experience in clinical development and strong leadership skills, with a focus on collaboration and communication.
Skills & Requirements
Must-have
Statistical strategy and methodology
Clinical trial design and data analysis
Regulatory interactions and submissions
Cross-functional team collaboration
External partner management
Nice-to-have
Influence in matrixed environment
Focus on program success probability
Communication of complex results
Key Requirements
PhD or MS/MA in statistics or related field
10+ years of experience in clinical development
Demonstrated leadership in statistical contributions