Principal Stats Programmer (VAX)
Core
Lead statistical programming for clinical trials across the Vaccines R&D value chain, delivering CDISC-compliant data packages and integrated clinical databases for regulatory submissions and reporting.
Role type
Principal Statistical Programmer (VAX)
Builds
CDISC SDTM/ADaM datasets, integrated clinical databases, and regulatory submission packages (e.g., DSUR, PBRER, ISS/ISE/ISI)
Domain
Biopharmaceuticals / Clinical Research / Vaccines
Required skills
SAS programming (BASE, STAT, MACRO, GRAPH, SQL), R, CDISC SDTM/ADaM standards, clinical trial processes, complex macro creation, data pooling across studies, project management
Preferred skills
e-submission preparation, controlled terminology expertise, value-level metadata management
Technologies
SAS, R, CDISC standards (SDTM, ADaM, define.xml)
Responsibilities
Plan and execute statistical programming deliverables; review study documents (protocol, SAP, CRF); create programming specifications; lead junior staff and ensure quality control; propose exploratory/post-hoc analyses; pool data from multiple studies.
Seniority
Principal, hands-on IC with leadership
