Associate Director I/II, Real World Data Statistics
Core
Lead the development of regulatory-grade evidence from real-world data (disease registries, patient cohorts) to support rare disease therapies and regulatory submissions.
Role type
Senior Individual Contributor (Associate Director)
Builds
Regulatory submissions, statistical analysis plans, briefing documents, and real-world evidence for rare disease programs.
Domain
Biopharmaceuticals / Real-World Evidence / Epidemiology
Required skills
Survival analysis, causal inference, propensity score matching, longitudinal modeling, registry data management, statistical programming, regulatory strategy, mentorship
Preferred skills
Peer-reviewed publications in pharmacoepidemiology, conference presentations, data linkage, missing data strategies
Technologies
R, SAS, SQL, Python
Responsibilities
Oversee design and implementation of advanced statistical analyses for regulatory submissions; Drive cross-functional collaboration with registry and regulatory teams; Oversee development of regulatory-quality deliverables; Validate statistical methodologies for real-world evidence; Mentor and guide other Real World Data Statisticians.
Seniority
Senior, hands-on IC with leadership responsibilities