Standards Engineer

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.

Job Functions:

• 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.

Minimum Requirements:

• 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.