Data Standards Engineer
Core
Design end-to-end client standards and study specifications aligned with CDISC standards and regulatory agency guidance.
Role type
Senior IC data standards engineer (CDISC)
Builds
Global tools and productivity tools for IQVIA and clients to support CDISC compliance and efficiency.
Domain
Life sciences / Clinical research / Regulatory standards
Required skills
CDISC Standards (SDTM, ADaM), SAS programming, statistical programming, macro/subroutine development, regulatory guidance knowledge, standards organization experience (CDISC, HL7, Transcelerate)
Preferred skills
R, Python, Julia, C#, Java, mentoring, regulatory submissions experience
Technologies
SAS, R, Python, Julia, C#, Java, metadata repositories
Responsibilities
Support clients and IQVIA as an authority in CDISC Standards use; Partner with statisticians to develop global tools; Lead implementation of productivity tools; Provide training and mentorship on technology and systems; Ensure work meets FDA Guidance and regulatory requirements; Guide clients in CDISC standards governance; Monitor regulatory updates; Represent IQVIA in industry standards development.
Seniority
Senior, hands-on IC
