Lead Biostatistician, Oncology (Remote)

Sumitomo Pharma; Boise (ID); Remote; USD 128,000 - 159,000; Full time

Benefits offered by this job

401(k) plan

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid time off

Holidays

Sick leave

Job summary

Sumitomo Pharma America, Inc. is seeking a Manager, Biostatistics (Oncology) to provide statistical leadership across oncology programs. You will lead one or more studies, shape SAPs, review CSRs, and work with CROs to ensure timely deliverables in a highly collaborative environment.

The role requires an MS or PhD in Statistics/ Biostatistics with 4+ years of relevant experience, strong regulatory knowledge, and excellence in communication for cross-functional teams and regulatory submissions.

Qualifications

• MS and 4 yrs of experience in Statistics, Biostatistics or related field or PhD in Statistics/ Biostatistics.
• Strong understanding of statistical principles and clinical trial methodology.
• Working knowledge of FDA, EMA, PMDA, ICH and other regulatory guidelines.
• Familiarity with CDISC SDTM and ADaM.
• Experience supporting design, analysis and reporting of clinical trials.
• Oncology clinical development experience preferred.
• Experience with CROs and external vendors is desirable.

Responsibilities

• Serve as lead statistician for oncology clinical studies.
• Provide statistical input into study design, endpoint selection, sample size, randomization, and analysis strategy.
• Contribute to development/review of SAPs and CSRs.
• Collaborate with programming to develop TLFs and analysis datasets.
• Review outputs for quality, consistency, and accuracy.
• Communicate results to cross-functional teams and regulatory partners.
• Support regulatory submissions and responses to health authorities.
• Provide technical guidance and mentoring to junior statisticians.

Skills

Statistical leadership

Cross-functional collaboration

Regulatory knowledge

SAS programming

R programming

Excellent communication

Education

MS in Statistics

PhD in Statistics

Tools

SAS

R

Job description

Sumitomo Pharma America, Inc. is seeking a Manager, Biostatistics (Oncology) to provide statistical leadership across oncology programs. You will lead one or more studies, shape SAPs, review CSRs, and work with CROs to ensure timely deliverables in a highly collaborative environment.

The role requires an MS or PhD in Statistics/ Biostatistics with 4+ years of relevant experience, strong regulatory knowledge, and excellence in communication for cross-functional teams and regulatory submissions.