Senior Biostatistics Manager – Oncology (Remote)

Sumitomo Pharma; Salem (OR); Remote; USD 128,000 - 159,000; Full time

Job summary

Sumitomo Pharma America provides oncology-focused leadership, seeking a Manager, Biostatistics (Oncology) to guide statistical work from protocol development through regulatory submission. You will lead studies, drive SAPs, and coordinate cross-functional teams including data management and medical writing.

We value SAS and R proficiency, CDISC SDTM/ADaM familiarity, and strong communication. This remote US role includes periodic on-site meetings and travel as needed, with a comprehensive

Qualifications

• MS and 4 yrs of experience in Statistics/Biostatistics or PhD in Statistics or related field.
• Strong understanding of regulatory guidelines (FDA/EMA/PMDA/ICH).
• Familiarity with CDISC SDTM and ADaM.
• Proficiency in SAS; R desirable.
• Oncology clinical development experience preferred.
• Ability to work cross-functionally in teams.

Responsibilities

• Serve as lead statistician for oncology clinical studies.
• Provide statistical input into study design, endpoints, sample size, randomization and analysis strategy.
• Develop and review Statistical Analysis Plans (SAPs).
• Collaborate on analysis datasets, tables, listings, and figures (TLFs).
• Support regulatory submissions and responses to health authorities.
• Mentor junior statisticians and collaborate with CROs.

Skills

Lead statistician

Biostatistics

SAS programming

R programming

CDISC standards

Regulatory submissions

Education

MS in Statistics

PhD in Statistics

Tools

SAS

R

CDISC SDTM/ADaM

Job description

Sumitomo Pharma America provides oncology-focused leadership, seeking a Manager, Biostatistics (Oncology) to guide statistical work from protocol development through regulatory submission. You will lead studies, drive SAPs, and coordinate cross-functional teams including data management and medical writing.

We value SAS and R proficiency, CDISC SDTM/ADaM familiarity, and strong communication. This remote US role includes periodic on-site meetings and travel as needed, with a comprehensive