Senior Biostatistics Lead, Oncology (Remote)

Sumitomo Pharma; Santa Fe (NM); À distance; USD 128 000 - 159 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Medical, dental, vision insurance

Life & disability insurance

Paid time off

Résumé du poste

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

Lead study statistics, collaborate with cross-functional teams, and mentor junior statisticians. This primarily remote role offers a base salary of $127,500–$159,400 per year, with a robust rewards package including 401(k), medical, dental, vision, life and disability insurances, and generous time off;

Qualifications

• MS and 4 yrs of experience in Statistics/Biostatistics or PhD in Statistics/Biostatistics.
• Strong understanding of statistical principles and clinical trial methodology.
• Working knowledge of FDA/EMA/PMDA/ICH guidelines.
• Familiarity with CDISC SDTM and ADaM; experience with SAS; R desirable.
• Experience supporting design, analysis and reporting of clinical trials.

Responsabilités

• Serve as lead statistician for oncology studies and collaborate with cross-functional teams.
• Input into study design, endpoints, sample size, randomization, and analysis strategy.
• Develop and review SAPs; contribute to CSR, abstracts, and regulatory documents.
• Review outputs and ensure quality and accuracy of deliverables; mentor junior staff.
• Support regulatory submissions and interactions with authorities.

Connaissances

Biostatistics

Statistical leadership

SAS programming

R language

Clinical trial method

Communication

Mentoring

Formation

MS in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Outils

SAS

R

Description du poste

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

Lead study statistics, collaborate with cross-functional teams, and mentor junior statisticians. This primarily remote role offers a base salary of $127,500–$159,400 per year, with a robust rewards package including 401(k), medical, dental, vision, life and disability insurances, and generous time off;