Oncology Biostatistics Lead (Remote)

Sumitomo Pharma

Augusta (ME)

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 insurance

Disability insurance

Flexible time off

Job summary

Sumitomo Pharma America in the U.S. (SMPA) is seeking a Manager, Biostatistics (Oncology) to provide statistical leadership for oncology clinical development programs from protocol development through regulatory submission.

You will lead one or more studies and collaborate with cross-functional teams to ensure high-quality trial deliverables. This remote, full-time role requires an MS with 4+ years in Biostatistics or a PhD, strong regulatory knowledge, SAS proficiency, and experience with CDISC

Qualifications

MS and 4 yrs of experience in Statistics/Biostatistics or a PhD in Statistics/Biostatistics
Strong understanding of statistical principles and clinical trial methodology
Familiarity with regulatory guidelines (FDA/EMA/PMDA) and CDISC standards

Responsibilities

Serve as lead statistician for oncology clinical studies.
Provide input on study design, endpoints, sample size, randomization, and analysis plans.
Develop and review SAPs and ensure quality of DT analyses (TLFs).
Collaborate with CROs, programming, and cross-functional teams to deliver high-quality deliverables.
Support regulatory submissions and responses to authorities.
Mentor junior statisticians and contribute to SOP improvements.