Principal Stats Programmer (VAX)
Core
Lead statistical programming for clinical trials across the Vaccines R&D value chain (Pre-Clinical, Clinical, Translational, CMC), delivering compliant CDISC data packages and integrated clinical databases.
Role type
Principal Statistical Programmer (Vaccines)
Builds
CDISC SDTM/ADaM datasets, integrated clinical databases, and statistical analysis plans for vaccine development.
Domain
Biopharmaceuticals / Clinical Research / Vaccines
Required skills
SAS programming (BASE, STAT, MACRO, GRAPH, SQL), R, CDISC SDTM/ADaM standards, complex macro creation, data pooling across studies, statistical analysis planning, quality control documentation.
Preferred skills
e-submission preparation, controlled terminology expertise, value-level metadata management.
Technologies
SAS, R, SQL, CDISC SDTM, CDISC ADaM, define.xml, Reviewers Guide.
Responsibilities
Write programming specifications for SDTM/ADaM/TLFs; create core integrated clinical databases pooling data from multiple studies; perform quality control and validation of statistical programming deliverables; propose and program exploratory or post-hoc analyses; lead junior staff and guide project execution.
Seniority
Principal, hands-on IC with leadership responsibilities.
