Lead Biostatistics, Oncology — US Remote

Sumitomo Pharma; Hartford (CT); Remote; USD 128,000 - 159,000; Full time

Job summary

Sumitomo Pharma in the US (Sumitomo Pharma America, Inc.) seeks a Manager, Biostatistics (Oncology) to provide statistical leadership across oncologic clinical development programs.

You will lead studies, contribute to study design, SAPs, CSRs, and regulatory submissions, and mentor junior statisticians. This role is primarily remote with periodic on-site meetings; requires an MS + 4 years (or PhD) in statistics/biostatistics and oncology experience.

Qualifications

• MS and 4 yrs of experience in Statistics/Biostatistics or related quantitative discipline, or PhD in Statistics/Biostatistics.
• Familiarity with CDISC standards, including SDTM and ADaM.
• Experience supporting the design, analysis, and reporting of clinical trials.
• Proficiency in SAS programming; R desirable.
• Strong analytical, problem-solving, and communication skills.
• Oncology clinical development experience preferred.
• Experience working with CROs and external vendors is desirable.

Responsibilities

• Serve as lead statistician for oncology clinical studies.
• Provide input into study design, endpoints, sample size, randomization, and analysis strategy.
• Contribute to SAPs and CSRs; review TLFs and analysis datasets.
• Collaborate with cross-functional teams to ensure regulatory submission readiness.
• Mentor junior statisticians and ensure high-quality deliverables.

Skills

Statistics

Biostatistics

Clinical trial methodology

Regulatory guidelines (FDA/EMA/ICH)

Cross-functional collaboration

Communication

Mentoring/junior staff

Education

MS in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Tools

SAS programming

R

Job description

Sumitomo Pharma in the US (Sumitomo Pharma America, Inc.) seeks a Manager, Biostatistics (Oncology) to provide statistical leadership across oncologic clinical development programs.

You will lead studies, contribute to study design, SAPs, CSRs, and regulatory submissions, and mentor junior statisticians. This role is primarily remote with periodic on-site meetings; requires an MS + 4 years (or PhD) in statistics/biostatistics and oncology experience.