Lead Oncology Biostatistics Manager (Remote)

Sumitomo Pharma America

United States

Remote

USD 128,000 - 159,000

Full time

3 days ago

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Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Flexible paid time off

Job summary

Sumitomo Pharma America seeks a Manager, Biostatistics (Oncology) to provide statistical leadership for oncology clinical programs from protocol development to submission. You will lead statisticians, collaborate with cross-functional teams, and contribute to CSRs, abstracts, and regulatory documents.

Ideal candidates have MS with 4+ years in statistics/biostatistics (PhD preferred), strong regulatory knowledge, and experience with CDISC SDTM/ADaM.

Qualifications

MS and 4 yrs of experience in statistics, biostatistics, or related quantitative discipline.
Strong understanding of statistical principles and clinical trial methodology.
Familiarity with FDA, EMA, PMDA, ICH, and other regulatory guidelines.
Experience with CDISC standards (SDTM/ADaM).
Experience supporting design, analysis and reporting of clinical trials.
Oncology clinical development experience preferred.

Responsibilities

Serve as lead statistician for one or more oncology clinical studies.
Provide statistical input into study design, endpoints, sample size, randomization, and analysis strategy.
Develop and review statistical analysis plans (SAPs).
Collaborate on CSRs, abstracts, publications, and regulatory documents.
Support regulatory submissions and responses to health authorities.
Mentor junior statisticians and guide CRO/statistical vendors.