IQVIA combines healthcare data analytics, advanced technology, and consulting to help organizations address complex challenges across the life sciences and healthcare sectors. Its Connected Intelligence platform brings together data and artificial intelligence to support clinical research, technology development, and the advancement of new therapies. The company’s teams work across analytics, consulting, and healthcare technology, offering opportunities connected to research, digital innovation, and efforts to improve patient outcomes.
Senior CDISC Data Standards Engineer
Apply CDISC standards, regulatory guidance, and automation tools at IQVIA. Support clinical research clients and global programming teams through submissions, training, and standards implementation.
Description
- Advise clients and IQVIA teams on applying CDISC standards through collaboration, training, and mentorship.
- Work with statisticians and programming teams to build global tools for project programming and CDISC implementation.
- Lead the rollout of productivity tools that strengthen compliance and improve delivery efficiency and timeliness.
- Train and mentor colleagues on technology and systems, including metadata repositories.
- Check client work against FDA submission requirements and other applicable regulatory guidance.
- Help clients interpret and apply CDISC standards through governance teams.
- Track updates from regulatory authorities and standards organizations, and share relevant changes with leadership.
- Represent CDISC standards in IQVIA initiatives.
- Take part in CDISC and other relevant industry standards groups and initiatives.
- Represent IQVIA in the industry on standards and automation.
- Help leadership develop and continually improve CDISC compliance processes and tools.
Requirements
- Bachelor’s degree in Computer Science, Statistics, Life Sciences, or a related discipline.
- Extensive knowledge of and experience applying CDISC standards.
- At least 7 years of SDTM experience.
- At least 5 years of ADaM experience.
- CDASH experience is desirable.
- Experience contributing to standards initiatives or working groups such as CDISC, HL7, TransCelerate, PHUSE, or similar organizations.
- Strong analytical and problem-solving abilities.
- Careful, accurate, consistent work that meets quality standards and applicable regulatory requirements.
- Strong communication, collaboration, and negotiation skills.
- Ability to assess study-specific needs and develop practical solutions that comply with standards.
- Ability to work independently and exercise sound judgment.
- Ability to balance multiple priorities and work effectively with cross-functional, global teams.
- More than 6 years of SAS programming experience is preferred.
- R or Python experience is advantageous.
- Experience mentoring and developing others in CDISC standards.
- Experience supporting regulatory authority submissions is preferred.
- Demonstrated interest and active participation in standards-related activities.