Remote Senior Oncology Biostatistics Lead

Sumitomo Pharma; Topeka (KS); Remote; USD 128,000 - 159,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision insurance

Paid time off

Job summary

Sumitomo Pharma America is seeking a Manager of Biostatistics (Oncology) to provide statistical leadership across oncology clinical development programs. The role requires an MS/PhD in statistics or biostatistics and strong SAS/R expertise.

The position is fully remote in the United States, with collaboration across Clinical Development, Regulatory, and external partners to ensure timely, compliant trial deliverables and successful regulatory submissions.

Qualifications

• MS or PhD in Statistics/Biostatistics or related quantitative discipline.
• Experience leading statistics for oncology clinical development.
• Working knowledge of FDA/EMA/ICH guidelines and CDISC standards.

Responsibilities

• Serve as lead statistician for oncology clinical studies.
• Provide statistical input into study design, endpoints, sample size and analysis plans.
• Prepare SAPs, CSRs, and regulatory submission documents.
• Collaborate with CROs and cross-functional teams to ensure high-quality deliverables.

Skills

Statistics/Biostatistics

SAS programming

R programming

Communication skills

Team collaboration

Education

MS in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Tools

SAS

R

CDISC SDTM

ADaM

Job description

Sumitomo Pharma America is seeking a Manager of Biostatistics (Oncology) to provide statistical leadership across oncology clinical development programs. The role requires an MS/PhD in statistics or biostatistics and strong SAS/R expertise.

The position is fully remote in the United States, with collaboration across Clinical Development, Regulatory, and external partners to ensure timely, compliant trial deliverables and successful regulatory submissions.