Data Standards Engineer (CDISC)
Core
Design end-to-end client standards and study specifications aligning to CDISC standards and regulatory agency guidance for IQVIA's life sciences clients.
Role type
Senior Data Standards Engineer (CDISC)
Builds
Global tools, productivity tools, and metadata repositories for IQVIA and clients to support CDISC compliance.
Domain
Life sciences / Clinical research / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
CDISC Standards (SDTM, ADaM), SAS programming, statistical programming, regulatory guidance interpretation, standards organization experience (CDISC, HL7, Transcelerate), macro/subroutine development, mentoring
Preferred skills
R, Python, Julia, C#, Java, pharmaceutical clinical trial data submissions
Technologies
SAS, R, Python, Julia, C#, Java, metadata repositories
Responsibilities
Partner with statisticians to develop global tools for CDISC programming needs; lead implementation of productivity tools to improve compliance and efficiency; provide training and mentorship on technology and systems; assure work meets FDA and regulatory submission requirements; monitor regulatory authority sites for updates; represent IQVIA in industry standards development.
Seniority
Senior, hands-on IC with mentorship responsibilities
