Principal Stats Programmer (VAX)
Core
Lead statistical programming for vaccines R&D across pre-clinical, clinical, and translational stages, delivering compliant CDISC data packages and integrated clinical databases.
Role type
Principal Statistical Programmer (Vaccines)
Builds
CDISC-compliant data packages (SDTM/ADaM/TLFs), integrated clinical databases, and regulatory submission artifacts for vaccine assets.
Domain
Biopharmaceuticals / Vaccines R&D
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
SAS programming (BASE, STAT, MACRO, GRAPH, SQL), R, CDISC SDTM/ADaM specifications, complex macro creation, multi-study data pooling, statistical analysis planning, quality control documentation
Preferred skills
e-submission preparation, controlled terminology expertise, value-level metadata management
Technologies
SAS, R, CDISC standards (SDTM, ADaM, define.xml)
Responsibilities
Write programming specifications for SDTM/ADaM/TLFs, create integrated clinical databases pooling data from multiple studies, lead junior staff on concurrent projects, perform quality control on statistical programming deliverables, propose exploratory and post-hoc analyses
Seniority
Principal, hands-on IC with leadership responsibilities