Lead Biostatistician, Oncology - Remote

Sumitomo Pharma

Atlanta (GA)

Remote

USD 128,000 - 159,000

Full time

2 days ago

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Job summary

Sumitomo Pharma America (SMPA) is seeking a Manager of Biostatistics (Oncology) to provide statistical leadership across oncology programs from design through regulatory submission. You will act as lead statistician for one or more trials, guiding analysis strategies and collaborating with cross‑functional teams to ensure high‑quality deliverables.

The role requires a strong background in statistics, trial methodology, and regulatory guidance, with experience in oncology development and CDISC

Qualifications

MS and 4+ years in statistics or a PhD equivalent.
Strong understanding of clinical trial methodology.
Familiarity with FDA/EMA/ICH guidelines.
CDISC SDTM/ADaM experience.
Proficiency in SAS; R desirable.
Excellent communication and cross‑functional collaboration.
Oncology clinical development experience preferred.
Experience with CROs and external vendors desirable.

Responsibilities

Serve as lead statistician for oncology studies.
Contribute to study design, endpoint selection, sample size, randomization methodology, and analysis strategy.
Develop and review SAPs (Statistical Analysis Plans).
Collaborate on analysis datasets, tables, listings, and figures (TLFs).
Review statistical outputs and ensure quality and accuracy.
Interpret results and communicate findings to project teams.
Support regulatory submissions and responses to health authorities.
Mentor junior statisticians as needed.