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Job Description
Structured overview of role & requirementsAbout This Role
Serve as a subject matter expert in CDISC standards, supporting clients and IQVIA through communication, training, and mentorship.
Lead development and implementation of tools and processes that improve compliance, efficiency, and timeliness of deliverables related to CDISC standards.
Monitor regulatory and standards updates, guiding clients on effective interpretation and application to meet submission requirements under FDA and other regulatory guidance.
Minimum Requirements
Bachelor’s degree in Computer Science, Statistics, Life Sciences, or related field.
Minimum 7 years of experience with SDTM and minimum 5 years with ADaM CDISC standards; experience with CDASH desirable.
Work Experience Required: More than 6 years of SAS programming experience preferred; involvement in industry standards initiatives required.
Strong regulatory submission knowledge and demonstrable experience mentoring others on CDISC standards; ability to manage multiple priorities in global teams.
Ideal Candidate Profile
Experienced in leading CDISC standards application and governance in clinical data submissions, preferably within global cross-functional environments.
Demonstrates strategic ability to develop pragmatic solutions balancing standards compliance with complex study-specific needs.
Actively engaged in industry standards development or working groups such as CDISC, PHUSE, or TransCelerate, indicating deep domain commitment and leadership potential.