Senior Statistical Programmer
Core
Develop, validate, and maintain complex clinical datasets, tables, listings, and figures for regulatory submissions and PK/PD modeling in pharmaceutical development.
Role type
Senior Statistical Programmer (Clinical Trials)
Builds
Regulatory submission packages (analysis datasets, tables, listings, figures) and PK/PD modeling deliverables
Domain
Pharmaceutical Development / Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis
Required skills
SAS programming, R programming, CDISC SDTM standards, CDISC ADaM standards, data manipulation, statistical analysis, algorithm design, analysis plan comprehension, pharmaceutical development processes
Preferred skills
Pharmacokinetic data analysis, clinical pharmacology concepts, large database management, Python, NonMem, software development life-cycle (SDLC), departmental macro development
Technologies
SAS, R, Python, NonMem
Responsibilities
Programmatically develop, validate, and maintain complex datasets, tables, listings, and figures; Provide technical consultation and analytical support to statisticians and PK modelers; Prepare compliant programming code for regulatory submissions; Ensure programmatic traceability from data source to analysis result; Support the development of programming standards
Seniority
Senior, hands-on IC