Remote Senior Oncology Biostatistics Manager

Sumitomo Pharma; Columbus (OH); Remote; USD 128,000 - 159,000; Full time

Job summary

Sumitomo Pharma America (SMPA) seeks a Manager, Biostatistics (Oncology) to lead statistical activities from protocol development through regulatory submission. You will serve as the lead statistician for multiple oncology studies and collaborate with cross-functional teams including Clinical Development, Regulatory, and Data Management.

Requires MS and at least 4 years in biostatistics (PhD preferred); strong SAS programming skills and CDISC SDTM/ADaM familiarity.

Qualifications

• MS or PhD in Statistics/Biostatistics or related field.
• Strong knowledge of statistical methods and clinical trial design.
• Experience with regulatory guidelines (FDA/EMA) and CDISC standards.

Responsibilities

• Lead statistician for oncology studies from protocol to CSR.
• Design studies, select endpoints, determine sample sizes, and define analysis plans.
• Prepare SAPs and review analysis datasets, tables, listings and figures.
• Collaborate with CROs and cross-functional teams to ensure timely deliverables.
• Support regulatory submissions and communicate results to stakeholders.

Skills

SAS programming

R programming

Statistical analysis

Communication skills

Cross-functional teamwork

Education

MS in Statistics

PhD in Statistics

Tools

SAS

R

CDISC SDTM

ADaM

Job description

Sumitomo Pharma America (SMPA) seeks a Manager, Biostatistics (Oncology) to lead statistical activities from protocol development through regulatory submission. You will serve as the lead statistician for multiple oncology studies and collaborate with cross-functional teams including Clinical Development, Regulatory, and Data Management.

Requires MS and at least 4 years in biostatistics (PhD preferred); strong SAS programming skills and CDISC SDTM/ADaM familiarity.