Oncology Biostatistics Manager – Remote Lead

Sumitomo Pharma; Carson City (NV); Remote; USD 128,000 - 159,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Paid time off

Holidays

Disability insurance

Life insurance

Job summary

Sumitomo Pharma America is seeking a Manager of Biostatistics (Oncology) to provide statistical leadership across oncology clinical development. You will lead statistician efforts for studies, influence design and endpoints, and collaborate across cross-functional teams to ensure high-quality analysis and regulatory readiness.

The role supports a remote-first environment with periodic on-site meetings, offering a competitive base salary and a full rewards package within a global pharma setting.

Qualifications

• MS and 4 yrs of experience in Statistics or Biostatistics, or PhD in related field.
• Strong understanding of regulatory guidelines (FDA, EMA, PMDA, ICH).
• Familiarity with CDISC standards, including SDTM and ADaM.
• Experience supporting the design, analysis, and reporting of clinical trials.
• Proficiency in SAS; experience with R is desirable.
• Oncology clinical development experience preferred.
• Experience working with CROs and external vendors desirable.

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 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

Clinical trial methodology

SAS programming

Communication skills

Cross-functional teamwork

Education

MS in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Tools

SAS

R

CDISC (SDTM/ADaM)

Job description

Sumitomo Pharma America is seeking a Manager of Biostatistics (Oncology) to provide statistical leadership across oncology clinical development. You will lead statistician efforts for studies, influence design and endpoints, and collaborate across cross-functional teams to ensure high-quality analysis and regulatory readiness.

The role supports a remote-first environment with periodic on-site meetings, offering a competitive base salary and a full rewards package within a global pharma setting.