Position Description:
Contract Biostatistician to support Medical Affairs and Real-World Evidence (RWE) activities, providing statistical leadership for RWE/observational studies, external comparator analyses, and evidence generation strategies. Collaborate with Medical, HEOR, Clinical Development, and Commercial.
Responsibilities:
- Partner with medical on publication strategies and HEOR/economic modeling inputs
- Provide statistical expertise using external control and/or synthetic control, meta-analyses, and causal inference (e.g., propensity score matching)
- Contribute to manuscripts, abstracts, and presentations
- Collaborate with HEOR to align analyses with HTA agency expectations
- Review protocols for RWE studies
- Support ad hoc analyses with statistical programmers; conduct quality review of analyses
- Perform statistical programming for advanced methodologies and help QC programmersβ work
- Review relevant medical literature
- Write statistical analysis plans
- Develop TLF shells and review programming specifications
Minimum Requirements:
- M.S. in Biostatistics or Ph.D. in Biostatistics (or equivalent) with at least 5 years of pharmaceutical/biotechnology (or equivalent) experience
Other Qualifications/Skills:
- Prior medical affairs and commercial experience
- Strong understanding of meta-analyses and causal inference; familiarity with RWE/HTA regulatory guidance
- Strong statistical reasoning/problem-solving; communicate complex methods to non-statisticians
- High data quality/methodological rigor; independent work in a fast-paced, cross-functional environment
- Good clinical practice guideline understanding
- Proficient statistical programming skills using relevant software
- Oncology experience preferred