Senior Real World Data Statistician I/II

Formulate and execute analytical strategies using real-world data (RWD), patient registries, natural history studies, and claims databases for rare disease programs.

Lead the design, execution, and validation of regulatory-grade statistical models, including survival analysis, causal inference, propensity score matching, and longitudinal modeling.

Address methodological challenges such as confounding, missing data, cohort construction, and data linkage in alignment with FDA RWE Framework and EMA registry guidelines.

Prepare regulatory deliverables, including Statistical Analysis Plans (SAP), analysis specifications, and briefing documents for global health authority submissions.

Collaborate cross-functionally with clinical, epidemiology, regulatory, and operations teams, as well as external registry investigators and consultants.

Present statistical findings and derived evidence at advisory committee meetings, regulatory interactions, and scientific conferences.