Lead Biostatistician, Oncology - Remote

Sumitomo Pharma; Madison (WI); 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, Inc. is seeking a Manager, Biostatistics (Oncology) to provide statistical leadership across oncology programs.

You will lead studies, shape design and analysis plans, and collaborate with Clinical Development, Statistics, Data Management, and Regulatory Affairs to ensure timely, high-quality deliverables. The role requires advanced statistical expertise, FDA/EMA knowledge, and experience with CDISC standards, SAS, and cross-functional teamwork.

Qualifications

• MS and 4 yrs of experience in Statistics or Biostatistics (or PhD in the field).
• Strong statistical principles and clinical trial methodology.
• Familiarity with FDA/EMA/PMDA guidelines.
• Experience with SAS; R experience desirable.
• Oncology clinical development experience preferred.
• Experience working with CROs and external vendors is desirable.

Responsibilities

• Serve as lead statistician for oncology studies and contribute to study design.
• Develop and review SAPs; participate in CSR preparation and regulatory submissions.
• Collaborate with data management, programming, and clinical teams to ensure quality deliverables.
• Review analyses, TLFs, and statistical outputs; communicate results to teams.
• Provide mentoring to junior statisticians and ensure regulatory compliance.

Skills

Statistics/Biostatistics

SAS programming

Regulatory knowledge

Communication

Cross-functional teamwork

Education

MS in Statistics/Biostatistics or PhD

Tools

SAS

R

CDISC SDTM/ADaM

Job description

Sumitomo Pharma America, Inc. is seeking a Manager, Biostatistics (Oncology) to provide statistical leadership across oncology programs.

You will lead studies, shape design and analysis plans, and collaborate with Clinical Development, Statistics, Data Management, and Regulatory Affairs to ensure timely, high-quality deliverables. The role requires advanced statistical expertise, FDA/EMA knowledge, and experience with CDISC standards, SAS, and cross-functional teamwork.