Director, Early-Phase Biostatistics (Oncology)

Daiichi Sankyo; Basking Ridge (NJ); On-site; USD 190,000 - 270,000; Full time

Job summary

Daiichi Sankyo is seeking a Director of Early Phase Biostatistics to provide leadership and hands-on statistics support for Early Development Oncology. You will guide study design, SAPs, CSR development, and regulatory interactions across multiple studies in a fast-paced setting.

The role requires a PhD in statistics or biostatistics, 7+ years in pharma/clinical research, and 3+ years in Early Phase oncology, with expertise in Bayesian methods, adaptive designs, and SAS/R.

Qualifications

• PhD in statistics or biostatistics required.
• 7+ years of relevant experience in the pharmaceutical industry and/or academic clinical research.
• 3+ years of experience in Early Phase clinical development, either in academic clinical research or biopharmaceutical industry.
• Demonstrated experience providing statistical leadership for complex Early Phase oncology programs and studies.
• Strong knowledge of statistical methodologies relevant to Early Phase development (Bayesian methods, adaptive designs, dose-finding, modeling & simulation).
• Experience supporting regulatory strategy and Health Authority interactions, including INDs and end-of-Phase 2 milestones.
• Proficiency in SAS and/or R.
• Strong communication skills for non-statistical stakeholders.

Responsibilities

• Provides hands-on statistical leadership and delivery across multiple Early Phase studies and serves as Biostatistics representative on GPTs and study teams.
• Leads or contributes to protocol development, CRF review, SAPs, analysis specs, modeling & simulation, CSR development, and regulatory documents.
• Reviews mock TFLs and performs quality review of ADaM datasets and TFLs for accuracy and consistency.
• Collaborates with Data Management, CROs, and other partners to ensure high-quality, timely delivery.
• Manages scope, timelines, priorities, dependencies, and resources for statistical deliverables; communicates risks.
• Provides statistical input to global regulatory strategies and Health Authority interactions.

Skills

Statistical leadership

Bayesian methods

Adaptive designs

Modeling & simulation

SAS

R

Education

PhD in statistics/biostatistics

Tools

SAS

R

Job description

Daiichi Sankyo is seeking a Director of Early Phase Biostatistics to provide leadership and hands-on statistics support for Early Development Oncology. You will guide study design, SAPs, CSR development, and regulatory interactions across multiple studies in a fast-paced setting.

The role requires a PhD in statistics or biostatistics, 7+ years in pharma/clinical research, and 3+ years in Early Phase oncology, with expertise in Bayesian methods, adaptive designs, and SAS/R.