Oncology Biostatistics Lead — Remote

Sumitomo Pharma; Saint Paul (MN); Remote; USD 128,000 - 159,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life and disability insurance

Flexible paid time off

11 paid holidays

Job summary

Sumitomo Pharma America (SMPA) is seeking a Manager, Biostatistics (Oncology) to provide statistical leadership across oncology development programs. The role leads statistical activities for one or more studies and collaborates with Clinical Development, Data Management, Regulatory Affairs, and CROs to ensure high-quality deliverables.

The position requires an MS/PhD in statistics with 4+ years in biostatistics, expertise in SAS, CDISC SDTM/ADaM, and strong communication skills.

Qualifications

• MS or PhD with 4+ years in statistics/biostatistics
• Strong understanding of statistical principles and trial methodology
• Experience with regulatory guidelines (FDA/EMA/ICH) and CDISC SDTM/ADaM
• Experience in design, analysis and reporting of clinical trials
• Proficiency in SAS; R desirable
• Excellent communication and cross-functional collaboration abilities
• Oncology clinical development experience preferred
• Experience with CROs and external vendors is desirable

Responsibilities

• Lead statistician for oncology clinical studies
• Contribute to study design, endpoint selection, sample size, randomization and analysis strategy
• Develop and review SAPs
• Collaborate on analysis datasets, TLFs, tables and figures
• Review outputs for quality and consistency; interpret results
• Contribute to CSRs, abstracts and regulatory submissions
• Support regulatory submissions and responses to health authorities
• Mentor junior statisticians and collaborate with CROs/vendors

Skills

Statistical leadership

Clinical trial statistics

FDA/EMA guidelines

CDISC SDTM/ADaM

SAS programming

R programming

Cross-functional collaboration

Communication skills

Oncology experience

Education

MS in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Tools

SAS

R

Job description

Sumitomo Pharma America (SMPA) is seeking a Manager, Biostatistics (Oncology) to provide statistical leadership across oncology development programs. The role leads statistical activities for one or more studies and collaborates with Clinical Development, Data Management, Regulatory Affairs, and CROs to ensure high-quality deliverables.

The position requires an MS/PhD in statistics with 4+ years in biostatistics, expertise in SAS, CDISC SDTM/ADaM, and strong communication skills.