Senior Biostatistics Lead - Late-Stage Trials

Daiichi Sankyo Co.; France; Remote; EUR 100,000 - 140,000; Full time

Job summary

Daiichi Sankyo is seeking a Senior Manager, Biostatistics (Late Stage) to lead complex studies in design, analysis and interpretation, with CRO supervision. Primary location is France, with Germany as a secondary site, collaborating with study teams and CRO statisticians on regulatory submissions.

You will direct protocol development, SAPs and CSR input, ensuring timely deliverables that align with regulatory requirements and product profiles.

Qualifications

• Master’s degree in statistics or biostatistics is required.
• PhD in statistics or biostatistics is preferred.
• 8+ years of pharmaceutical industry experience with a master’s degree.
• 5+ years of pharmaceutical industry experience with a PhD preferred.

Responsibilities

• Protocol development, CRF review, SAP development and CSR input.
• Leads statistical activities for complex studies including design and analysis.
• Acts as main statistical contact for assigned studies and projects.
• Guides study team on statistics and collaborates with CRO data managers.
• Provides input to development plans to ensure regulatory compliance and efficiency.
• Reviews CRO/vendor proposals and oversees deliverables and timelines.
• Contributes to documents submitted to Health Authorities globally.

Skills

Statistical analysis

Study design

CRO/vendor oversight

Regulatory documentation input

Education

Master’s degree in statistics or biostatistics

PhD in statistics or biostatistics

Job description

Daiichi Sankyo is seeking a Senior Manager, Biostatistics (Late Stage) to lead complex studies in design, analysis and interpretation, with CRO supervision. Primary location is France, with Germany as a secondary site, collaborating with study teams and CRO statisticians on regulatory submissions.

You will direct protocol development, SAPs and CSR input, ensuring timely deliverables that align with regulatory requirements and product profiles.