Remote Oncology Biostatistics Manager

Sumitomo Pharma; United States; Remote; USD 128,000 - 159,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Paid time off

11 holidays + shutdown time

Sick time

Job summary

Sumitomo Pharma America (SMPA) is seeking a Manager, Biostatistics (Oncology) to provide statistical leadership across oncology programs from protocol to regulatory submission. You will lead one or more studies, collaborate with Clinical Development, Medical Writing, Regulatory Affairs, and CROs to ensure high-quality deliverables.

Ideal candidates hold an MS with 4+ years in biostatistics or a PhD, with SAS; experience in CDISC SDTM/ADaM and regulatory guidelines is preferred.

Qualifications

Responsibilities

• Lead statistician for oncology clinical studies and provide input on study design, endpoints, sample size, and randomization.
• Authors and reviews SAPs; collaborates on TLFs and study reports.
• Supports regulatory submissions and responses to health authorities.

Education

MS and 4 yrs of experience in Statistics/Biostatistics or PhD in Statistics/Biostatistics

Tools

SAS

R

Job description

Sumitomo Pharma America (SMPA) is seeking a Manager, Biostatistics (Oncology) to provide statistical leadership across oncology programs from protocol to regulatory submission. You will lead one or more studies, collaborate with Clinical Development, Medical Writing, Regulatory Affairs, and CROs to ensure high-quality deliverables.

Ideal candidates hold an MS with 4+ years in biostatistics or a PhD, with SAS; experience in CDISC SDTM/ADaM and regulatory guidelines is preferred.