Associate Director I/II, Real World Data Statistics
Core
Lead the development of regulatory-grade evidence from real-world data (disease registries, EMR, claims) to support rare disease therapy approvals and label expansions.
Role type
Senior Individual Contributor (Associate Director) in Real World Data Statistics
Builds
Regulatory submissions, statistical analysis plans, briefing documents, and regulatory-grade evidence packages for rare disease programs
Domain
Biopharmaceuticals / Rare Diseases / Real-World Evidence (RWE)
Required skills
Advanced statistical modeling (survival, causal inference, propensity score, longitudinal), registry data expertise, regulatory science knowledge, R, SAS, SQL/Python, mentorship
Preferred skills
Peer-reviewed publications in pharmacoepidemiology, experience with FDA/EMA registry guidance, external stakeholder management
Technologies
R, SAS, SQL, Python
Responsibilities
Oversee design and implementation of advanced statistical analyses for regulatory submissions; Drive cross-functional collaboration on registry-derived analyses; Oversee development of regulatory-quality deliverables (SAPs, tables, briefing docs); Mentor and build capability for other Real World Data Statisticians
Seniority
Senior, hands-on IC with leadership responsibilities