Remote Oncology Biostatistics Manager

Sumitomo Pharma

Frankfort (KY)

Remote

USD 128,000 - 159,000

Full time

2 days ago

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Job summary

Sumitomo Pharma America is seeking an experienced Manager, Biostatistics (Oncology) to provide statistical leadership across oncology programs. You will serve as lead statistician for studies, design analyses, and collaborate with cross-functional teams to ensure regulatory-compliant deliverables.

The role emphasizes SAS programming with R desirable, regulatory knowledge, and mentoring of junior staff in a fast-paced, remote-capable setting.

Qualifications

MS with 4+ years in Statistics/Biostatistics or a PhD in Statistics/Biostatistics or related field.
Strong understanding of statistical principles and trial methodology.
Working knowledge of FDA/EMA/PMDA/ICH and applicable guidelines.
Familiarity with CDISC standards, including SDTM and ADaM.
Experience in design, analysis, and reporting of clinical trials.
Proficiency in SAS; R experience desirable.
Oncology clinical development experience preferred.
Experience with CROs and external vendors is desirable.

Responsibilities

Lead statistician for one or more oncology studies.
Interpret and communicate results to cross-functional teams.
Contribute to study design, endpoints, sample size, randomization, and analysis plan.
Author and review SAPs and CSRs; prepare analyses datasets and TLFs.
Support regulatory submissions and responses to authorities.
Mentor junior statisticians and collaborate with CROs/partners.