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

Remote · Germany Full-time

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.

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