Senior Oncology Biostatistician (Remote)

Sumitomo Pharma; Harrisburg (Dauphin County); Remote; USD 128,000 - 159,000; Full time

Benefits offered by this job

Merit-based raises

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Paid time off

Job summary

Sumitomo Pharma is seeking a Manager of Biostatistics (Oncology) to lead statistical leadership for oncology programs from design to regulatory submission. You will serve as lead statistician for studies, shape analysis plans, and ensure high-quality deliverables with cross-functional teams.

The role requires MS/PhD in statistics with 4+ years of biostatistics experience, SAS expertise, and strong communication. Oncologic development background and CRO collaboration are preferred.

Qualifications

• MS and 4+ years in Statistics/Biostatistics or PhD in Statistics/Biostatistics.
• Strong understanding of statistical principles and trial methodology.
• Experience with regulatory guidelines (FDA/EMA/PMDA/ICH).
• Familiarity with CDISC SDTM/ADaM standards.
• Proficiency in SAS; familiarity with R is desirable.

Responsibilities

• Serve as lead statistician for oncology clinical studies.
• Provide statistical input into study design, endpoints and sample size.
• Develop and review SAPs and CSRs; collaborate on TLFs.
• Support regulatory submissions and responses to health authorities.
• Mentor junior statisticians and collaborate with CROs.

Skills

Statistics

Clinical trial methodology

Regulatory guidelines

CDISC SDTM/ADaM

SAS

R (desirable)

Communication

Cross-functional collaboration

Education

MS or PhD in Statistics

Tools

SAS programming

R (desirable)

Job description

Sumitomo Pharma is seeking a Manager of Biostatistics (Oncology) to lead statistical leadership for oncology programs from design to regulatory submission. You will serve as lead statistician for studies, shape analysis plans, and ensure high-quality deliverables with cross-functional teams.

The role requires MS/PhD in statistics with 4+ years of biostatistics experience, SAS expertise, and strong communication. Oncologic development background and CRO collaboration are preferred.