Remote Senior Biostatistics Lead – Clinical Development

Sumitomo Pharma; Richmond (VA); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking an Associate Director, Biostatistics to provide strategic statistical leadership across one or more clinical development programs.

You will shape study design, analysis plans, regulatory submissions, and external collaborations, partnering with cross-functional leaders to ensure rigorous, feasible statistical deliverables. The role requires a PhD in statistics/biostatistics or equivalent with 5+ years in pharma/biotech, expertise in SAS/R, CDISC, and

Qualifications

• PhD in Statistics or Biostatistics with ≥5 years in pharma/biotech.
• MS with ≥8 years in pharmaceutical/biotech acceptable.
• Experience leading clinical development programs and trials.

Responsibilities

• Serve as biostatistics lead for clinical programs and design strategies.
• Lead regulatory interactions and briefing documents.
• Oversee protocols and SAPs development and review.
• Provide statistical interpretation and risk mitigation.
• Mentor statisticians and programmers.
• Collaborate with cross-functional teams and senior leadership.
• Apply Bayesian or adaptive trial methods when appropriate.

Skills

Biostatistics leadership

Clinical trial design

Regulatory knowledge

SAS

R

Communication

Cross-functional

Regulatory interactions

Education

PhD in Statistics/Biostatistics

MS in related field

Tools

SAS

R

CDISC

Job description

Sumitomo Pharma America, Inc. is seeking an Associate Director, Biostatistics to provide strategic statistical leadership across one or more clinical development programs.

You will shape study design, analysis plans, regulatory submissions, and external collaborations, partnering with cross-functional leaders to ensure rigorous, feasible statistical deliverables. The role requires a PhD in statistics/biostatistics or equivalent with 5+ years in pharma/biotech, expertise in SAS/R, CDISC, and