Senior Statistical Programmer
Core
Senior Statistical Programmer creating derived analysis datasets and clinical Tables, Figures, and Listings (TFLs) to support regulatory submissions for new medicines.
Role type
Senior individual contributor statistical programmer
Builds
Regulatory submission packages (NDA, BLA, MAA) and clinical analysis datasets
Domain
Biopharmaceuticals / Clinical Data Science
Required skills
SAS programming, CDISC standards (SDTM, ADaM), clinical data structures, upstream data handling, downstream output generation, statistical analysis planning
Preferred skills
Vendor management, process efficiency improvement
Technologies
SAS, eDC, relational databases
Responsibilities
Writing and validating SAS programs to generate derived analysis datasets and TFLs; Contributing to electronic submission preparation (NDA, BLA, MAA); Reviewing and shaping Statistical Analysis Plans (SAPs) and Data Presentation Plans; Partnering with vendors on programming standards and file transfers; Independently leading programming assignments across multiple projects; Spotting opportunities to improve efficiency and consistency across the team