Oncology Biostatistics Lead (Remote)

Sumitomo Pharma; Montpelier (VT); Remote; USD 128,000 - 159,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking a Manager of Biostatistics (Oncology) to provide statistical leadership across oncology programs, from protocol development to regulatory submission.

You will serve as lead statistician on trials and collaborate with Clinical Development, Programming, Data Management, and Regulatory Affairs. The role requires an MS or PhD in Statistics with several years in biostatistics, strong knowledge of regulatory guidelines, and proficiency in SAS (R desirable).

Qualifications

• MS in Statistics or PhD in Statistics with 4+ years in biostatistics.
• Strong understanding of clinical trial methodology and regulatory guidelines.
• Experience with CDISC SDTM/ADaM.
• Proficiency in SAS; R desirable.
• Experience leading statistics for oncology trials.

Responsibilities

• Serve as lead statistician for one or more oncology clinical studies.
• Provide statistical input into study design, endpoint selection, sample size determination, randomization methodology, and analysis strategy.
• Contribute to the development and review of clinical study protocols.
• Author and review Statistical Analysis Plans (SAPs).
• Collaborate with Statistical Programming in the development and review of analysis datasets, tables, listings, and figures (TLFs).
• Review statistical outputs and ensure the quality, consistency, and accuracy of study deliverables.
• Interpret study results and communicate findings to multidisciplinary project teams.
• Contribute to the preparation of Clinical Study Reports (CSRs), abstracts, publications, and regulatory documents.
• Support regulatory submissions and responses to health authorities.
• Collaborate with CRO statisticians and programming teams to ensure timely and high-quality deliverables.
• Ensure compliance with regulatory requirements, company procedures, and industry standards.
• Participate in departmental initiatives to improve statistical processes and standards.
• Provide technical guidance and mentoring to junior statisticians as needed.

Skills

Statistical leadership

SAS programming

R programming

Communication skills

Cross-functional collaboration

Regulatory knowledge

Education

MS in Statistics

PhD in Statistics

Tools

SAS

R

Job description

Sumitomo Pharma America, Inc. is seeking a Manager of Biostatistics (Oncology) to provide statistical leadership across oncology programs, from protocol development to regulatory submission.

You will serve as lead statistician on trials and collaborate with Clinical Development, Programming, Data Management, and Regulatory Affairs. The role requires an MS or PhD in Statistics with several years in biostatistics, strong knowledge of regulatory guidelines, and proficiency in SAS (R desirable).