Principal Programmer/Associate Manager - Statistical Programming, Central Services
Core
Lead statistical programming for integrated analysis, regulatory submissions, and clinical trial disclosure activities.
Role type
Associate Manager, Statistical Programming
Builds
Integrated datasets, pooled analysis datasets, reports, and programming documentation for regulatory submissions and clinical transparency.
Domain
Biotechnology / Pharmaceutical / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
SAS programming (Base, STAT, Macro, Graph), CDISC standards (SDTM, ADaM, Define-XML), Pinnacle 21 validation, eCTD submission formats, project management, people management
Preferred skills
R, Python, SAS certification
Technologies
SAS, Pinnacle 21, eCTD
Responsibilities
Create integrated and pooled analysis datasets and reports; support preparation and review of electronic data packages for regulatory submissions; coordinate with Clinical Transparency and Trial Disclosure teams; develop tools and standard processes to improve efficiency; troubleshoot programming and validation issues; support inspection readiness activities.
Seniority
Manager, hands-on IC with team leadership