Lead Biostatistician, Oncology (Remote)

Sumitomo Pharma; Annapolis (MD); Remote; USD 128,000 - 159,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Paid time off

Job summary

Sumitomo Pharma America (SMPA) is seeking a Manager, Biostatistics (Oncology) to provide statistical leadership across oncology programs from protocol development to regulatory submission. The role leads statisticians and collaborates with Clinical Development, Data Management, Medical Writing, and Regulatory Affairs in a global company.

The ideal candidate has MS or PhD in statistics/biostatistics with 4+ years of experience, strong regulatory knowledge, proficiency in SAS and R, and oncology

Qualifications

• MS or PhD in Statistics/Biostatistics or related field.
• Strong regulatory knowledge for FDA/EMA/ICH/PMDA.
• Experience designing, analyzing, and reporting clinical trials.
• Oncology trial experience preferred.

Responsibilities

• Lead statisticians for oncology studies and design input.
• Develop SAPs and collaborate on TLFs and CSR deliverables.
• Support regulatory submissions and health authority responses.
• Mentor junior statisticians and ensure quality outputs.

Skills

Statistical leadership

SAS programming

R programming

Clinical trials

Regulatory knowledge

Communication skills

CDISC SDTM/ADaM

Team mentoring

Education

MS in Biostatistics

PhD in Statistics

Tools

SAS

R

CDISC Standards

Job description

Sumitomo Pharma America (SMPA) is seeking a Manager, Biostatistics (Oncology) to provide statistical leadership across oncology programs from protocol development to regulatory submission. The role leads statisticians and collaborates with Clinical Development, Data Management, Medical Writing, and Regulatory Affairs in a global company.

The ideal candidate has MS or PhD in statistics/biostatistics with 4+ years of experience, strong regulatory knowledge, proficiency in SAS and R, and oncology