Senior Biostatistics Lead for Oncology Trials

Sumitomo Pharma; Marlborough (MA); On-site; USD 130,000 - 190,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking a Senior Manager, Biostatistician to lead statistical activities in oncology development from protocol through regulatory submission.

You will serve as lead on studies, guide design, endpoints, analysis plans, and collaborate with cross-functional teams to ensure high-quality deliverables. The role requires strong statistical expertise, experience with regulatory guidelines, and ability to mentor junior statisticians while coordinating with CROs and

Qualifications

• MS or PhD in Statistics, Biostatistics, or a related quantitative discipline.
• Minimum 1 year of relevant industry experience with a PhD, or 3 years with an MS degree.
• Strong understanding of statistical principles and clinical trial methodology.
• Working knowledge of FDA, EMA, PMDA, ICH, and other applicable regulatory guidelines.
• Familiarity with CDISC SDTM and ADaM.
• Experience supporting design, analysis, and reporting of clinical trials.
• Proficiency in SAS; experience with R is desirable.

Responsibilities

• Serve as lead statistician for oncology clinical studies.
• Provide statistical input into study design, endpoints, sample size, randomization, and analysis strategy.
• Contribute to SAP development and review.
• Collaborate on data analysis datasets, TLFs, and outputs.
• Review statistics and ensure quality of study deliverables.
• Interpret results and communicate findings to cross-functional teams.
• Support CSRs, abstracts, publications, and regulatory documents.

Skills

Clinical trial design

Statistical analysis

Regulatory collaboration

Project management

Mentoring

Effective communication

Education

PhD in Statistics

MS in Statistics

Tools

SAS

R

Job description

Sumitomo Pharma America, Inc. is seeking a Senior Manager, Biostatistician to lead statistical activities in oncology development from protocol through regulatory submission.

You will serve as lead on studies, guide design, endpoints, analysis plans, and collaborate with cross-functional teams to ensure high-quality deliverables. The role requires strong statistical expertise, experience with regulatory guidelines, and ability to mentor junior statisticians while coordinating with CROs and