CDISC Standards Engineer - Data Governance & Automation

IQVIA Holdings Inc.; Reading; On-site; GBP 70,000 - 110,000; Full time

Job summary

IQVIA Holdings Inc. in Reading, United Kingdom, seeks a CDISC Standards Specialist to shape end-to-end design and study specifications aligned to CDISC standards and regulatory guidance.

You will collaborate with statisticians and programming teams to develop global tools, lead productivity improvements, and mentor clients on governance and regulatory updates while ensuring high-quality submissions.

Qualifications

• Bachelor's Degree in computer science, statistics, or related area.
• CDISC Standards experience, 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; macro/subroutine knowledge.
• Proficiency in SAS, R, Python, Julia, C#, Java, or similar languages.
• Relevant statistical programming experience with pharmaceutical clinical trial data.
• Experience in mentoring and developing others in CDISC standards.
• Experience in submissions to regulatory authority.

Responsibilities

• Design end-to-end client standards and study specifications aligned to CDISC standards and regulatory guidance.
• Partner with project statisticians and programming teams to develop global tools for CDISC programming needs.
• Lead implementation of productivity tools to improve compliance, efficiencies, and timeliness of deliverables.
• Provide training and mentorship for the use of technology and systems including metadata repositories.
• Ensure work delivered meets FDA submission requirements and other regulatory guidance.
• Guide clients in their use of CDISC standards through governance teams.

Skills

Strong communication

Mentoring

Regulatory submissions

Education

Bachelor's degree in CS/Stats/related

Tools

SAS

R

Python

Java

Job description

IQVIA Holdings Inc. in Reading, United Kingdom, seeks a CDISC Standards Specialist to shape end-to-end design and study specifications aligned to CDISC standards and regulatory guidance.

You will collaborate with statisticians and programming teams to develop global tools, lead productivity improvements, and mentor clients on governance and regulatory updates while ensuring high-quality submissions.