CDISC Standards Engineer — Data & Regulatory Lead

IQVIA; Dublin; On-site; EUR 120,000 - 180,000; Full time

Job summary

IQVIA Ireland seeks a senior CDISC specialist to lead end-to-end design of client standards and study specifications aligned with regulatory guidance, including FDA expectations. You will collaborate with statisticians and programming teams to craft global tools supporting CDISC workflows and ensure compliant deliverables.

This role also involves mentoring teams in CDISC usage, SDTM/ADaM implementations, and regulatory submissions, while guiding governance and tooling initiatives across projects.

Qualifications

• Bachelor's degree in computer science, statistics, or related field.
• Extensive experience with CDISC SDTM and ADaM.
• Experience on industry teams involved in 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.
• Experience in regulatory submissions preferred.

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 Standards

SDTM

ADaM

SAS

R

Python

Java

Mentoring

Regulatory submissions

Education

Bachelor's degree in computer science, statistics, or related field

Tools

SAS

R

Python

Java

C#

Job description

IQVIA Ireland seeks a senior CDISC specialist to lead end-to-end design of client standards and study specifications aligned with regulatory guidance, including FDA expectations. You will collaborate with statisticians and programming teams to craft global tools supporting CDISC workflows and ensure compliant deliverables.

This role also involves mentoring teams in CDISC usage, SDTM/ADaM implementations, and regulatory submissions, while guiding governance and tooling initiatives across projects.