Principal Statistical Programmer
Core
Leading statistical programming for clinical studies, regulatory submissions, and ad hoc analysis to support clinical development programs.
Role type
Principal Statistical Programmer
Builds
Regulatory submission packages (eCTD), SDTM/ADaM datasets, and statistical analysis reports
Domain
Biopharmaceuticals / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SAS Base, SAS STAT, SAS Graph, SAS Macro, CDISC standards (SDTM, ADaM), GCP regulations, FDA/ICH guidelines, 21 CFR Part 11, vendor management, team mentoring
Preferred skills
eCTD electronic submissions, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE)
Technologies
SAS, eCTD
Responsibilities
Lead and support programming activities for clinical studies and regulatory submissions; Develop and manage specifications for SDTM and ADaM datasets; Create global standard macros to enhance group efficiency; Mentor less experienced programmers; Oversee adherence to protocols and statistical analysis plans
Seniority
Principal, hands-on IC with mentorship
