Lead Biostatistics Manager - Late-Stage Oncology

Daiichi Sankyo Co.; France; À distance; EUR 110 000 - 150 000; Plein temps

Résumé du poste

Daiichi Sankyo is seeking a Senior Manager, Biostatistics (Late Stage Oncology) based primarily in France with Germany as an alternative location. You will lead complex studies in design, analysis, and interpretation, guiding CRO programmers and statisticians while interacting with study teams and Health Authorities.

The role emphasizes global regulatory documentation, collaboration across teams, and strategic input to drug development plans with minimal supervision. Travel up to 10% is possible.

Qualifications

• Master's degree in statistics or biostatistics required.
• PhD in statistics or biostatistics preferred.
• 8+ years of pharma experience with a master's degree; 5+ years with a PhD preferred.

Responsabilités

• Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review.
• Acts as main statistical contact for the assigned studies and projects.
• Provides guidance to study team on all aspects of statistical activities; collaborates with data manager to ensure high quality data.
• Supports Drug Development Strategy by providing input to development plans to ensure scientifically sound designs and regulatory readiness.
• Oversees CRO/vendor interactions, budgets, and deliverables to ensure timely, accurate analyses.

Connaissances

Statistical analysis

Study design

CRO oversight

Data interpretation

Regulatory interactions

Formation

Master's Degree in statistics or biostatistics

PhD in statistics or biostatistics

Description du poste

Daiichi Sankyo is seeking a Senior Manager, Biostatistics (Late Stage Oncology) based primarily in France with Germany as an alternative location. You will lead complex studies in design, analysis, and interpretation, guiding CRO programmers and statisticians while interacting with study teams and Health Authorities.

The role emphasizes global regulatory documentation, collaboration across teams, and strategic input to drug development plans with minimal supervision. Travel up to 10% is possible.