Lead Biostatistician, Oncology — Remote

Sumitomo Pharma

Dover (DE)

Remote

USD 128,000 - 159,000

Full time

3 days ago

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Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life and disability insurance

Flexible PTO

Holidays

Sick leave

Job summary

Sumitomo Pharma America (SMPA) is seeking a Manager, Biostatistics (Oncology) to lead statistical activities across oncology clinical development and ensure rigorous analyses for regulatory submissions. You will collaborate with cross-functional teams to deliver high-quality results in a fast-paced environment.

The role requires an MS with 4 years of statistics/biostatistics or a PhD, strong regulatory knowledge, and proficiency in SAS; R is desirable.

Qualifications

MS and 4 yrs of experience in Statistics, Biostatistics, or a related discipline, or PhD in Statistics/Biostatistics.
Strong understanding of clinical trial methodology and regulatory guidelines.
Experience with CDISC SDTM/ADaM and CRO collaboration.

Responsibilities

Serve as lead statistician for oncology studies.
Provide input on study design, endpoints, sample size, randomization, and analysis strategy.
Draft and review SAPs.
Collaborate with programming to develop analysis datasets, tables, listings, and figures (TLFs).
Review statistical outputs for quality, consistency, and accuracy.
Support regulatory submissions and health authority responses.
Mentor junior statisticians as needed.