Principal Biostatistician Consultant - Remote (experience working with medical affairs and commercial)
Core
Provide statistical leadership in the design, analysis, and interpretation of Real-World Evidence (RWE) and observational studies to support post-marketing, payer, and hypothesis generation activities.
Role type
Principal Biostatistician Consultant (RWE/HEOR)
Builds
Evidence generation strategies, manuscripts, abstracts, and analyses for Medical Affairs and Commercial teams
Domain
Pharmaceutical/Biotechnology - Real-World Evidence (RWE) and Health Economics and Outcomes Research (HEOR)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
RWE study design, external control/synthetic control analyses, meta-analyses, causal inference (propensity score matching), statistical programming, TLF development, regulatory guidance knowledge, oncology domain knowledge
Preferred skills
Oncology experience
Technologies
SAS, R, Python (implied by statistical programming context)
Responsibilities
Partner with medical for publication strategies and HEOR modeling inputs; Provide statistical expertise in external control and causal inference analyses; Contribute to manuscripts, abstracts, and presentations; Collaborate with HEOR to align analyses with HTA agency expectations; Review protocols for RWE studies; Conduct quality review of statistical analyses; Perform statistical programming for advanced methodologies; Write statistical analysis plans; Develop TLF shells and review programming specs
