CDISC Data Standards Engineer | SDTM/ADaM Expert

IQVIA; Amsterdam; On-site; EUR 90,000 - 130,000; Full time

Job summary

IQVIA is seeking a CDISC Standards expert to lead end-to-end design of client standards and study specifications aligned with CDISC guidelines. The role collaborates with statisticians and programming teams to build global tools and governance for compliant submissions.

The candidate will mentor others, implement productivity tools, and monitor regulatory updates to ensure timely, high-quality deliverables across global clients.

Qualifications

• Bachelor's 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.

Responsibilities

• Support clients and IQVIA 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 IQVIA and clients which improve compliance, efficiencies, 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.

Skills

CDISC SDTM/ADaM

SAS programming

Programming languages

Macro/subroutine development

Strong communication

Regulatory submissions

Mentoring others

CDISC/HL7/TransCelerate

CDISC standards experience

Experience with CDISC Standards

Education

Bachelor's Degree in computer science, statistics, or a related area

Job description

IQVIA is seeking a CDISC Standards expert to lead end-to-end design of client standards and study specifications aligned with CDISC guidelines. The role collaborates with statisticians and programming teams to build global tools and governance for compliant submissions.

The candidate will mentor others, implement productivity tools, and monitor regulatory updates to ensure timely, high-quality deliverables across global clients.