Early Phase Biostatistics Lead — Associate Director

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

Job summary

Daiichi Sankyo is seeking an Associate Director Biostatistics, Early Phase in New Jersey to lead complex early-phase studies, including dose-escalation and dose-expansion, with statistical design, analysis, interpretation and reporting.

The role provides scientific oversight of CRO activities, partners with cross-functional teams, and supports Health Authority documents while ensuring timely, high-quality deliverables.

Qualifications

• Master's degree in statistics or biostatistics required; PhD preferred.
• 8+ years in pharma with master's degree or 5+ years with PhD.
• Minimum 2 years supporting Early Phase drug development studies (dose-escalation/expansion/optimization).
• Proficiency in SAS and/or R required; Bayesian methods, adaptive designs, dose-finding are valued.

Responsibilities

• Leads statistical activities for complex early phase studies, including dose-escalation, dose-expansion, and dose-optimization; develops protocols, reviews CRFs, SAPs, and CSR inputs.
• Provides scientific leadership and acts as main statistical contact for assigned studies and CRO/vendor oversight.
• Contributes to Health Authority submissions and meetings; supports cross-functional study execution and data interpretation.
• Supports global development strategy and harmonization of statistical deliverables to accelerate timelines.

Skills

Communication

Statistical consultation

Cross-functional collaboration

Education

Master's degree in statistics or biostatistics

PhD in statistics or biostatistics

Tools

SAS

R

Job description

Daiichi Sankyo is seeking an Associate Director Biostatistics, Early Phase in New Jersey to lead complex early-phase studies, including dose-escalation and dose-expansion, with statistical design, analysis, interpretation and reporting.

The role provides scientific oversight of CRO activities, partners with cross-functional teams, and supports Health Authority documents while ensuring timely, high-quality deliverables.