Principal Biostatistician Consultant - Remote (experience working with medical affairs and commercial)
About the position 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. 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
- 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
Requirements
- M.S., Biostatistics or Ph.D. in Biostatistics or equivalent with at least 5 years of pharmaceutical, biotechnology, or equivalent experience.
- 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
Nice-to-haves
- Oncology experience preferred