Senior Biostatistics Manager - Oncology, Remote

Sumitomo Pharma; Boston (MA); Remote; USD 128,000 - 159,000; Full time

Job summary

Sumitomo Pharma America is seeking a Manager, Biostatistics (Oncology) to lead statistical activities across oncology programs. You will act as the primary statistician for multiple studies, guiding design, analysis, and regulatory submissions while collaborating with Clinical Development, Data Management, and other partners.

You will ensure adherence to CDISC SDTM/ADaM, regulatory expectations, and high-quality deliverables.

Qualifications

• MS and 4+ years in Statistics/Biostatistics or a related field (or PhD).
• Strong principles of statistics and trial methodology.
• Familiarity with FDA/EMA/ICH guidelines and CDISC standards (SDTM/ADaM).
• Experience supporting design, analysis, and reporting of clinical trials.
• Proficiency in SAS; R experience desirable.

Responsibilities

• Serve as lead statistician for oncology studies.
• Contribute to protocol design, SAPs, and CSR development.
• Prepare and review TLFs, datasets, and regulatory submissions.
• Collaborate with CROs and cross-functional teams to ensure timely deliverables.
• Mentor junior statisticians and provide technical guidance.

Skills

Statistical leadership

Cross-functional collaboration

Communication skills

Analytical thinking

Problem solving

Mentoring junior statisticians

Education

MS in Statistics/Biostatistics or related

PhD in Statistics/Biostatistics or related

Tools

SAS programming

R

CDISC SDTM/ADaM

Job description

Sumitomo Pharma America is seeking a Manager, Biostatistics (Oncology) to lead statistical activities across oncology programs. You will act as the primary statistician for multiple studies, guiding design, analysis, and regulatory submissions while collaborating with Clinical Development, Data Management, and other partners.

You will ensure adherence to CDISC SDTM/ADaM, regulatory expectations, and high-quality deliverables.