Principal Biostatistician Consultant - Remote (experience working with medical affairs and commercial)

Location: United States

Department: Biostatistics

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 an Principal 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.

Position Description:

We are seeking an experienced Contract Biostatistician to support Medical Affairs and Real‑World Evidence (RWE) activities. The role will provide statistical leadership in the design, analysis, and interpretation of RWE/observational studies, external comparator analyses, and evidence generation strategies to support post‑marketing, payer, and hypothesis generation analysis. This position requires close collaboration with cross-functional teams including Medical, HEOR, Clinical Development, and Commercial.

Responsibilities and Duties:

• Partner with medical for publication strategies, HEOR or economic modeling inputs
• Provide statistical expertise in analyses using external control and/or synthetic control, meta-analyses, and causal inference analyses, e.g. propensity score matching method
• Contribute to manuscripts, abstracts and presentations
• Collaborate with HEOR to align analyses with HTA agency expectations
• Review protocols for real world evidence studies
• Work with statistical programmers to conduct ad hoc analyses; Conduct quality review of statistical analyses
• Perform statistical programming for advanced statistical methodologies and help statistical programmers QC their programs
• Review relevant medical literature
• Write statistical analysis plans
• Develop TLF shells and review programming specs 

Minimum Requirements:

Experience: 

• M.S., Biostatistics or Ph.D. in Biostatistics or equivalent with at least 5 years of pharmaceutical, biotechnology, or equivalent experience.

Other:

• Prior experience working with medical affairs and commercial
• Good understanding of meta-analyses and causal inference methodologies
• Familiarity with regulatory guidance on RWE and HTA requirements
• Strong statistical reasoning and problem-solving
• Ability to communicate complex methods to non-statistical stakeholders
• High attention to data quality and methodological rigor
• Ability to work independently in a fast-paced, cross-functional environment
• Understand good clinical practice guidelines
• Good statistical programming skills using relevant statistical software
• Oncology experience preferred

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