IQVIA is looking to appoint Standards Engineer to support clients and organization as an authority in the use of CDISC Standards through communication, training, and mentorship.
- Partner with project statisticians and programming teams to develop global tools to support project programming needs in the use of CDISC Standards
- Lead the implementation of productivity tools for IQVIA and clients which improve compliance and timeliness of deliverables to clients.
- Provide training and mentorship for the use of technology and systems, such as metadata repositories, to support IQVIA and client’s in their use.
- Assures that work delivered to clients meet minimum submission requirements as defined by FDA Guidance Documents and other regulatory guidance.
- Guide clients in their use of CDISC standards through governance teams.
- Monitors regulatory authority and standards organization sites for updates and informs IQVIA leadership of updates.
- Work on other IQVIA initiatives as a CDISC representative.
- Interact with various CDISC sanctioned teams in the development of standards.
- Represent IQVIA in the industry as a leader in the use of Standards and Automation
- Support leadership in the development of processes and tools which enable CDISC compliance.
- Bachelor's Degree in computer science, statistics, or a related area
- Experience with CDISC Standards, specifically SDTM and ADaM
- Experience on an industry team involved in standards such as CDISC, HL7, or Transcelerate.
- Strong communication skills
- 10 years SAS programming experience or other related programming language experience preferred. Knowledge of macro or subroutine development is expected.
- Knowledge and experience in two or more programming languages such as SAS, R, Python, Julia, C#, Java, or other language
- Relevant statistical programming experience with pharmaceutical clinical trial data preferred
- Experience in mentoring and developing others in the use of CDISC standards
- Experience in submissions to regulatory authority preferred
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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