Associate Director I/II, Real World Data Statistics
Core
Lead the development of regulatory-grade evidence from disease registries and longitudinal observational cohorts to support rare disease therapies and regulatory submissions.
Role type
Senior Individual Contributor (Associate Director) in Real World Data Statistics
Builds
Regulatory submissions, statistical analysis plans, briefing documents, and registry-derived evidence for FDA/EMA
Domain
Biopharmaceuticals / Rare Diseases / Real-World Evidence (RWE)
Required skills
Advanced statistical modeling (survival, causal inference, propensity score, longitudinal), registry data management, regulatory science expertise, R, SAS, SQL/Python, mentorship
Preferred skills
Peer-reviewed publications in pharmacoepidemiology, experience with external registry investigators, conference presentations
Technologies
R, SAS, SQL, Python
Responsibilities
Oversee design and implementation of advanced statistical analyses for regulatory submissions; Drive cross-functional collaboration on registry interactions; Oversee development of regulatory-quality deliverables; Validate statistical methodologies for RWE generation; Mentor and guide other Real World Data Statisticians
Seniority
Senior, hands-on IC with leadership responsibilities