Lead Oncology Biostatistics Manager - Remote

Sumitomo Pharma; Jackson (MS); 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 from protocol through regulatory submission.

You will serve as the lead statistician for clinical studies, influence study design, analysis strategies, and SAPs, and collaborate with cross-functional teams to ensure high-quality deliverables and regulatory readiness.

Qualifications

• MS or PhD in Statistics/Biostatistics or related field.
• Strong understanding of clinical trial methodology and statistics.
• Familiarity with FDA, EMA, PMDA, ICH guidelines.
• Experience with CDISC SDTM/ADaM standards.
• Experience supporting oncology trials and regulatory submissions.
• Proficiency in SAS programming; knowledge of R desirable.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Lead statistician for one or more oncology clinical studies.
• Provide statistical input into study design, endpoints, and analysis plans.
• Develop and review SAPs and statistical outputs.
• Contribute to CSRs, abstracts, publications, and regulatory documents.
• Collaborate with CROs and internal teams to ensure timely deliverables.

Skills

Statistics

Biostatistics

Clinical trials

SAS programming

R language

Regulatory knowledge

CDISC SDTM/ADaM

Team 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 from protocol through regulatory submission.

You will serve as the lead statistician for clinical studies, influence study design, analysis strategies, and SAPs, and collaborate with cross-functional teams to ensure high-quality deliverables and regulatory readiness.