Oncology Biostatistics Lead - Remote

Sumitomo Pharma America, Inc; Town of Marlborough (NY); Remote; USD 128,000 - 159,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) plan with company match

PTO and paid holidays

Shut-down period time off

Job summary

Sumitomo Pharma America, Inc. seeks a Manager, Biostatistics (Oncology) to provide statistical leadership across oncology development, from protocol design to regulatory submission.

Lead statistics for multiple studies and collaborate with cross-functional teams to ensure timely, high-quality deliverables. Required MS/PhD in statistics/biostatistics with 4+ years in clinical statistics, strong regulatory knowledge, CDISC SDTM/ADaM, and SAS; R a plus.

Qualifications

• MS or PhD in Statistics, Biostatistics, or related quantitative discipline.
• 5+ years of experience in statistics/biostatistics in clinical development.
• Strong understanding of regulatory guidelines (FDA/EMA/ICH).
• Familiarity with CDISC SDTM/ADaM standards and SAS programming.

Responsibilities

• Lead statistician for oncology clinical studies.
• Contribute to study design, endpoints, sample size, randomization, analysis strategy.
• Author/review SAPs; develop analysis datasets, tables, listings, figures (TLFs).
• Interpret results and communicate to cross-functional teams.
• Support regulatory submissions and responses to authorities.

Skills

Statistical leadership

Study design input

SAS programming

R programming

Cross-functional collaboration

Communication skills

Education

MS in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Tools

SAS

CDISC SDTM/ADaM

R

Job description

Sumitomo Pharma America, Inc. seeks a Manager, Biostatistics (Oncology) to provide statistical leadership across oncology development, from protocol design to regulatory submission.

Lead statistics for multiple studies and collaborate with cross-functional teams to ensure timely, high-quality deliverables. Required MS/PhD in statistics/biostatistics with 4+ years in clinical statistics, strong regulatory knowledge, CDISC SDTM/ADaM, and SAS; R a plus.