Senior Biostatistics Lead, Late-Stage Oncology

Daiichi Sankyo; Basking Ridge (NJ); On-site; USD 175,000 - 263,000; Full time

Job summary

Daiichi Sankyo is seeking an Associate Director, Biostatistics (Late Stage Oncology) to lead complex studies, contribute to development plans, and guide CRO statisticians. The role interfaces with study teams, data managers, and regulators to deliver rigorous analyses and timely results in global drug development.

Senior biostatistist leadership is required, with extensive experience in late-stage oncology trials and CRO coordination to ensure quality analysis files and regulatory-ready outputs.

Qualifications

• Must have strong statistical expertise in late-stage clinical trials.
• Experience leading complex studies and interacting with study teams.
• Ability to guide CROs and programmers in analysis deliverables.

Responsibilities

• Lead statistical activities for complex late-stage oncology studies.
• Collaborate with data managers to ensure high quality data.
• Provide input to development plans and regulatory submissions.
• Oversee CRF review, SAP development, and CSR input.
• Interact with Health Authorities and global teams on analyses.
• Mentor statisticians and programmers in CROs.

Skills

Biostatistics

Study design

CRO oversight

Education

Master's Degree in statistics or biostatistics

PhD in statistics or biostatistics preferred

Job description

Daiichi Sankyo is seeking an Associate Director, Biostatistics (Late Stage Oncology) to lead complex studies, contribute to development plans, and guide CRO statisticians. The role interfaces with study teams, data managers, and regulators to deliver rigorous analyses and timely results in global drug development.

Senior biostatistist leadership is required, with extensive experience in late-stage oncology trials and CRO coordination to ensure quality analysis files and regulatory-ready outputs.