Senior Director, Biostatistics – Remote

Sumitomo Pharma; Carson City (NV); Remote; USD 166,000 - 207,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking an Associate Director, Biostatistics to lead statistics for one or more clinical development programs, providing strategic input on design, analysis, regulatory submissions, and data interpretation in a fast-paced environment.

This role collaborates with cross-functional teams, oversees CRO activities, and mentors statisticians and programmers, with emphasis on Bayesian methods, adaptive designs, and rigorous governance.

Qualifications

• PhD in Statistics or Biostatistics with at least 5 years of pharma/biotech experience.
• Significant experience providing statistical leadership for clinical programs.
• Experience supporting regulatory interactions is preferred.

Responsibilities

• Serve as biostatistics lead for clinical development programs and design decisions.
• Represent Biostatistics on cross-functional teams.
• Lead statistical interactions with regulatory authorities and prepare responses.
• Oversee the development and review of protocols, SAPs, submissions, and other documents.
• Provide statistical interpretation of results and support data-driven decisions.
• Oversee CROs and external vendor statistical activities and timelines.

Skills

Statistical principles

Regulatory guidance

CDISC standards

SAS

R

Communication

Leadership

Education

PhD in Statistics/Biostatistics

MS in a quantitative field

Tools

SAS

R

Job description

Sumitomo Pharma America, Inc. is seeking an Associate Director, Biostatistics to lead statistics for one or more clinical development programs, providing strategic input on design, analysis, regulatory submissions, and data interpretation in a fast-paced environment.

This role collaborates with cross-functional teams, oversees CRO activities, and mentors statisticians and programmers, with emphasis on Bayesian methods, adaptive designs, and rigorous governance.