Associate Director, Biostatistics — Late-Stage Oncology

Initial Therapeutics, Inc.; Basking Ridge (NJ); On-site; USD 175,000 - 263,000; Full time

Job summary

Daiichi Sankyo, Inc. in the United States seeks an Associate Director, Biostatistics (Late Stage Oncology) to lead complex studies, design, analysis and interpretation with minimal supervision. You will guide CROs and statisticians and contribute to regulatory documents for Health Authorities globally.

In this role you will interact with study teams and CRO personnel, ensuring rigorous analyses and timely delivery across late-stage oncology programs.

Qualifications

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

Responsibilities

• Protocol Development, CRF review, SAP development, analysis files, CSR input and review.
• Leads statistical activities for complex studies including study design and analysis.
• Acts as main statistical contact for assigned studies and projects.
• Guides study teams and collaborates with data managers to ensure high data quality.
• Provides input to development plans to ensure scientifically sound study designs.
• Review CRO/vendor proposals and budgets; set deliverables and timelines.
• Contributes to documents submitted to Health Authorities and may participate in meetings.
• Participates in global strategies to improve drug development efficiency.

Skills

Biostatistics expertise

Clinical trial statistics

Statistical study design

Education

Master's Degree in statistics or biostatistics

PhD in statistics or biostatistics

Job description

Daiichi Sankyo, Inc. in the United States seeks an Associate Director, Biostatistics (Late Stage Oncology) to lead complex studies, design, analysis and interpretation with minimal supervision. You will guide CROs and statisticians and contribute to regulatory documents for Health Authorities globally.

In this role you will interact with study teams and CRO personnel, ensuring rigorous analyses and timely delivery across late-stage oncology programs.