Senior Biostatistics Lead (Remote) for Clinical Programs

Sumitomo Pharma; Helena (MT); Remote; USD 166,000 - 207,000; Full time

Benefits offered by this job

Medical insurance

401(k)

Paid time off

Job summary

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

The role involves strategic oversight from planning to regulatory submissions, with collaboration across functions to ensure rigorous, feasible statistical approaches. The position emphasizes expertise in Bayesian and adaptive designs, CRO/vendor oversight, and mentorship of statisticians, in a primarily remote setting with domestic and

Qualifications

• PhD or MS with substantial experience in pharmaceutical/biotech clinical development.

Responsibilities

• Serve as statistical lead for one or more clinical development programs and provide input into plans, study designs, and analysis strategies.
• Represent Biostatistics on cross-functional teams and ensure statistical considerations in key decisions.
• Lead statistical interactions with regulatory authorities, including briefing documents and responses to questions.
• Author or oversee statistical sections of protocols, SAPs, submissions, publications, and other scientific documents.
• Provide interpretation of study results, communicate risk-benefit considerations, and support data-driven program decisions.

Skills

Statistical leadership

Cross-functional collaboration

Regulatory interactions

Data analysis

Mentorship and coaching

Education

PhD in Statistics/Biostatistics

MS in pharma/biotech with 8+ years experience

Tools

SAS

R

Job description

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

The role involves strategic oversight from planning to regulatory submissions, with collaboration across functions to ensure rigorous, feasible statistical approaches. The position emphasizes expertise in Bayesian and adaptive designs, CRO/vendor oversight, and mentorship of statisticians, in a primarily remote setting with domestic and