Principal Biostatistician Consultant- Remote in US (Oncology)

About this role

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for anPrincipal Biostatistician Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Job Summary

We are seeking an experienced Principal Biostatistician to provide statistical leadership for oncology clinical development programs. This role will support Phase I–III clinical trials and contribute to regulatory submissions while collaborating closely with cross-functional teams.

Key Responsibilities

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Provide statistical leadership for oncology clinical trials across multiple phases (Phase I–III).

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Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs).

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Design and review statistical methodologies for efficacy and safety analyses.

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Oversee analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards.

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Support interim analyses, data monitoring committee (DMC) activities, and adaptive designs.

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Collaborate with clinical development, data management, programming, regulatory, and medical teams.

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Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries (FDA, EMA).

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Provide strategic input on study design, endpoint selection, and sample size…