Data Standards Engineer (CDISC) - m/w/d
IQVIA
IQVIA seeks a Data Standards Engineer to serve as a CDISC authority, supporting clients and internal teams in standards implementation, compliance, and training. The role involves developing tools, mentoring staff, and representing the company within industry standards organizations.
Responsibilities
- Act as CDISC standards authority through communication, collaboration, training, and mentorship
- Partner with statisticians and programmers to develop tools supporting CDISC implementation
- Lead implementation of productivity tools to improve compliance and efficiency
- Ensure deliverables meet FDA guidance and regulatory submission requirements
- Monitor regulatory and standards organization updates and communicate changes to leadership
Requirements
- Bachelor's degree in Computer Science, Statistics, Life Sciences, or related field
- Minimum 7 years of SDTM experience and 5 years of ADaM experience
- Strong analytical and problem-solving skills with ability to interpret regulatory guidance
- Excellent communication and stakeholder collaboration abilities
- More than 6 years of SAS programming experience preferred
- Experience with industry standards initiatives (CDISC, HL7, TransCelerate, PHUSE, or similar)
- Preferred: regulatory submission support experience and mentoring in CDISC standards
Vacancy posted 1 day ago
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