Lead Biostatistician, Oncology — Remote

Sumitomo Pharma; Salt Lake City (UT); Remote; USD 128.000 - 159.000; Vollzeit

Benefits dieser Stelle

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life and disability insurances

Flexible paid time off

Zusammenfassung

Sumitomo Pharma America (SMPA) is seeking a Manager of Biostatistics (Oncology) to provide statistical leadership across oncology programs. You will lead study statistics, design input, SAPs/analysis, and regulatory support while collaborating with cross-functional teams in a primarily remote US role.

The role requires an MS with several years in statistics or a PhD, strong regulatory knowledge, and SAS; R is desirable.

Qualifikationen

• MS with 4+ years in statistics/biostatistics or a PhD in a related field.
• Strong understanding of clinical trial methodology and statistics.
• Familiarity with FDA, EMA, ICH guidelines and CDISC standards.

Aufgaben

• Lead statistician for oncology studies and collaborate across cross-functional teams.
• Contribute to study design, endpoint selection, sample size and analysis plans.
• Author and review SAPs and CSRs, and support regulatory submissions.
• Review outputs for quality, consistency, and regulatory compliance.
• Mentor junior statisticians and guide statistical processes.

Kenntnisse

Statistics

Biostatistics

Regulatory knowledge

SAS

R

Communication skills

Cross-functional collaboration

Ausbildung

MS in Statistics/Biostatistics or related

PhD in Statistics/Biostatistics or related

Tools

SAS programming

R programming

Jobbeschreibung

Sumitomo Pharma America (SMPA) is seeking a Manager of Biostatistics (Oncology) to provide statistical leadership across oncology programs. You will lead study statistics, design input, SAPs/analysis, and regulatory support while collaborating with cross-functional teams in a primarily remote US role.

The role requires an MS with several years in statistics or a PhD, strong regulatory knowledge, and SAS; R is desirable.