Principal Biostatistician Consultant - Remote (experience working with medical affairs and commercial)
This a Full Remote job, the offer is available from: United States 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
#LI-TT1 #LI-Remote #Principal#Contract This offer from "ClinChoice" has been enriched by Jobgether.com and got a 74% flex score.