Oncology Biostatistics Lead (Remote)

Sumitomo Pharma; Trenton (NJ); Remote; USD 128,000 - 159,000; Full time

Job summary

Sumitomo Pharma is seeking a Manager of Biostatistics (Oncology) to lead statistical activities across oncology programs from protocol development to regulatory submission. You will collaborate with cross-functional teams to ensure timely, high-quality trial deliverables.

The role requires an MS with several years in biostatistics or a PhD, strong SAS skills, and knowledge of CDISC standards. Remote work with periodic on-site meetings is typical in this US-based position.

Qualifications

• MS and 4 yrs of experience in Statistics/Biostatistics or a PhD in Statistics/Biostatistics or related quantitative discipline.
• Strong understanding of statistical principles and clinical trial methodology.
• Familiarity with CDISC standards (SDTM/ADaM) and regulatory guidelines.

Responsibilities

• Serve as lead statistician for oncology clinical studies.
• Provide statistical input into study design, endpoints, sample size, randomization, and analysis strategy.
• Author and review SAPs and analysis datasets, tables, listings, and figures (TLFs).
• Support regulatory submissions and responses to health authorities.

Skills

Statistical leadership

Lead statistician

SAS programming

R (desirable)

Regulatory knowledge

Cross-functional collaboration

Effective communication

Education

MS in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Tools

SAS

R

Job description

Sumitomo Pharma is seeking a Manager of Biostatistics (Oncology) to lead statistical activities across oncology programs from protocol development to regulatory submission. You will collaborate with cross-functional teams to ensure timely, high-quality trial deliverables.

The role requires an MS with several years in biostatistics or a PhD, strong SAS skills, and knowledge of CDISC standards. Remote work with periodic on-site meetings is typical in this US-based position.