Senior Director, Early Phase Biostatistics - Oncology

Daiichi Sankyo; Basking Ridge (NJ); On-site; USD 240,000 - 340,000; Full time

Job summary

Daiichi Sankyo, in the United States, is seeking a Senior Director, Biostatistics to head the Early Phase Biostatistics group supporting EDO. The role leads statistical strategy, delivers SAPs and protocols, and partners with cross-functional teams to advance oncology programs from proof-of-concept to late-stage development.

You will guide methodological innovation, manage resources, and represent Biostatistics in regulatory discussions, ensuring high-quality deliverables, biomarker analyses,

Qualifications

• PhD in statistics or Biostatistics required.
• 10+ years of pharma industry experience.
• 4+ years supervisory experience.
• 4+ years Early Phase oncology development experience.
• Expertise in Bayesian and adaptive methods.
• Experience supporting regulatory submissions and IND/EOP2.
• Proficiency in SAS and/or R.
• Strong written and verbal communication skills.

Responsibilities

• Provide strategic Biostatistics leadership across the Early Phase portfolio.
• Shape study design, endpoint selection, and dose optimization.
• Lead regulatory interactions and briefing package development.
• Oversee group capabilities, staffing, and resource planning.
• Collaborate with global teams across time zones.
• Ensure timely delivery of CSRs and DSURs with quality.

Skills

Biostatistics

Leadership

Statistical methods

Regulatory

Cross-functional

SAS/R

Education

PhD in statistics or Biostatistics

Tools

SAS

R

Job description

Daiichi Sankyo, in the United States, is seeking a Senior Director, Biostatistics to head the Early Phase Biostatistics group supporting EDO. The role leads statistical strategy, delivers SAPs and protocols, and partners with cross-functional teams to advance oncology programs from proof-of-concept to late-stage development.

You will guide methodological innovation, manage resources, and represent Biostatistics in regulatory discussions, ensuring high-quality deliverables, biomarker analyses,