Head of Early-Phase Biostatistics & Strategy

Daiichi Sankyo, Inc.; Basking Ridge (NJ); On-site; USD 202,000 - 303,000; Full time

Job summary

Daiichi Sankyo, Inc. is seeking a Director of Biostatistics to provide statistical leadership for Early Development Oncology in the U.S. The role leads study design, SAPs, TFL reviews, and cross-functional collaboration across GPTs and CROs.

The candidate should hold a PhD in statistics or biostatistics, have 7+ years in pharma or clinical research and 3+ years in Early Phase development, and be proficient in SAS and R. Travel up to 20% is required.

Qualifications

• PhD in statistics or biostatistics required.
• 7+ years of relevant experience in pharma or clinical research.
• 3+ years of Early Phase development experience.
• Proficiency in SAS and R; strong communication and leadership skills.
• Experience providing statistical leadership for oncology programs and cross-functional teams.

Responsibilities

• Provides hands-on statistical leadership and delivery across multiple Early Phase studies and serves as Biostatistics representative on GPTs and study teams.
• Leads protocol development, SAPs, analysis specifications, modeling/simulation, CSR development and regulatory documents.
• Reviews mock TFLs and performs quality review of ADaM datasets and TFLs for accuracy and regulatory readiness.
• Collaborates with Data Management, CROs, and other partners to ensure high-quality, timely delivery.
• Plans scope, timelines, priorities, and resources; communicates risks and manages CRO/vendor activities.
• Supports global regulatory strategy and Health Authority interactions as needed.

Skills

Statistical leadership

Bayesian methods

Adaptive designs

Team leadership

Communication

Education

PhD in statistics or biostatistics

Tools

SAS

R

Job description

Daiichi Sankyo, Inc. is seeking a Director of Biostatistics to provide statistical leadership for Early Development Oncology in the U.S. The role leads study design, SAPs, TFL reviews, and cross-functional collaboration across GPTs and CROs.

The candidate should hold a PhD in statistics or biostatistics, have 7+ years in pharma or clinical research and 3+ years in Early Phase development, and be proficient in SAS and R. Travel up to 20% is required.