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
Location: Syndax's corporate office is in New York, NY.
This is a remote opportunity.
