Lead Biostatistician, Oncology – Remote

Sumitomo Pharma; Lincoln (NE); Remote; USD 128,000 - 159,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking a Manager of Biostatistics (Oncology) to provide statistical leadership from protocol development through regulatory submission.

You will serve as the lead statistician for oncology studies, guiding SAPs, TLFs, and CSR preparation while collaborating with cross-functional teams to ensure high-quality trial deliverables. Remote US position with periodic on-site meetings; strong FDA/EMA/CDISC experience and SAS programming are required.

Qualifications

• MS and 4 yrs of experience in Statistics/Biostatistics or a PhD in the field.
• Strong understanding of statistical principles and clinical trial methodology.
• Experience with regulatory guidelines and CDISC standards (SDTM/ADaM).
• Proficiency in SAS; knowledge of R desirable.

Responsibilities

• Serve as lead statistician for oncology clinical studies.
• Provide statistical input into study design, endpoints, and sample size.
• Develop and review SAPs and analysis datasets, tables, listings, and figures.
• Review outputs for quality and accuracy; interpret results for teams.
• Contribute to CSRs, abstracts, publications, and regulatory submissions.
• Collaborate with CRO statisticians and programming teams to ensure timely deliverables.
• Mentor junior statisticians and ensure regulatory compliance.

Skills

Biostatistics

Statistics

Clinical trial methodology

Regulatory guidelines (FDA/EMA/ICH)

SAS programming

R programming

Communication skills

Cross-functional collaboration

Education

MS in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Tools

SAS

R

Job description

Sumitomo Pharma America, Inc. is seeking a Manager of Biostatistics (Oncology) to provide statistical leadership from protocol development through regulatory submission.

You will serve as the lead statistician for oncology studies, guiding SAPs, TLFs, and CSR preparation while collaborating with cross-functional teams to ensure high-quality trial deliverables. Remote US position with periodic on-site meetings; strong FDA/EMA/CDISC experience and SAS programming are required.