Data Standards Engineer

• Support us and our clients as an authority in the use of CDISC Standards through communication, collaboration, 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 us and our clients that improve compliance, efficiencies, and timeliness of deliverables
• Provide training and mentorship in the use of technology and systems, such as metadata repositories, to support our and our clients use
• Assure that work delivered to clients meets minimum submission requirements as defined by FDA Guidance Documents and other regulatory guidance
• Guide clients in the use of CDISC standards through governance teams
• Monitor regulatory authority and standards organization sites for updates and inform leadership of updates
• Work on other initiatives as a CDISC representative
• Interact with various CDISC-sanctioned teams in the development of standards
• Represent us 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

Technologies:

• C#
• HL7
• Support
• Java
• Julia
• Python
• SAS

• Bachelors degree in computer science, statistics, or a related area
• Experience with CDISC Standards, specifically SDTM and ADaM
• Experience on industry teams 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

We are IQVIA, a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. This is a full-time role based in Reading, Berkshire, United Kingdom; Frankfurt, Hesse, Germany; or Amsterdam, Netherlands. We are committed to integrity in our hiring process and maintain a zero-tolerance policy for candidate fraud. All information and credentials submitted in the application must be truthful and complete.