Principal Biostatistician Consultant – Medical Affairs, Commercial
Job Description:
- 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
- Oncology experience preferred.
Benefits:
- Health insurance
- Professional development opportunities