Senior Biostatistics Manager - Oncology (Remote)

Sumitomo Pharma; Providence (RI); 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. This role requires strong collaboration with cross-functional teams to ensure rigorous study design and compliant reporting.

The candidate will develop SAPs, review analysis datasets, and contribute to CSRs and regulatory submissions, while mentoring junior statisticians in a fast-paced environment. Remote work with occasional on-site meetings is offered.

Qualifications

• MS with 4+ years in statistics/biostatistics or PhD in Statistics/Biostatistics.
• Strong understanding of clinical trial methodology.
• Familiarity with FDA/EMA/PMDA/ICh guidelines and CDISC SDTM/ADaM.

Responsibilities

• Lead statistician for oncology clinical studies.
• Provide input on study design, endpoints, and sample size.
• Develop and review SAPs and TLFs.
• Collaborate on CSR preparation and regulatory submissions.
• Mentor junior statisticians and ensure high-quality deliverables.

Skills

Biostatistics

Clinical trials

SAS programming

Regulatory knowledge

Communication skills

Cross-functional collaboration

Education

MS in Statistics

PhD in Statistics

Tools

SAS

R

Job description

Sumitomo Pharma America is seeking a Manager, Biostatistics (Oncology) to lead statistical activities across oncology programs. This role requires strong collaboration with cross-functional teams to ensure rigorous study design and compliant reporting.

The candidate will develop SAPs, review analysis datasets, and contribute to CSRs and regulatory submissions, while mentoring junior statisticians in a fast-paced environment. Remote work with occasional on-site meetings is offered.