Head of Biostatistics, Oncology — Remote

Sumitomo Pharma

Bismarck (ND)

Remote

USD 128.000 - 159.000

Vollzeit

Vor 3 Tagen

Sei unter den ersten Bewerbenden

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Benefits dieser Stelle

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life and disability insurance

Flexible PTO

11 paid holidays

Zusammenfassung

Sumitomo Pharma America (SMPA) is seeking a Manager, Biostatistics (Oncology) to lead statistical oversight for oncology programs from design through regulatory submission. You will serve as the lead statistician for one or more studies, guiding SAP development, TLF creation, and analysis strategies while ensuring QA across deliverables.

Ideal candidates hold an MS or PhD, with 4+ years in biostatistics or statistics, strong SAS skills, knowledge of CDISC SDTM/ADaM, and a track-record in

Qualifikationen

MS or PhD in Statistics/ Biostatistics or related field with 4+ years of experience.
Strong knowledge of statistical principles and clinical trial methodology.
Experience with FDA/EMA/ICH guidelines and CDISC standards.

Aufgaben

Lead statistician for oncology clinical studies and regulatory submissions.
Provide input on study design, endpoints, sample size, randomization, and analysis plans.
Authors and reviews SAPs; collaborates on TLFs and CSRs.
Ensure quality and accuracy of statistical deliverables and communications.

Kenntnisse

SAS programming

R programming

Regulatory knowledge

Statistical methods

Cross-functional collaboration

Ausbildung

MS in Statistics

PhD in Statistics

Tools

CDISC SDTM

CDISC ADaM

SAS

Jobbeschreibung