CDISC Standards Engineer - SDTM/ADaM Expert

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

Job summary

IQVIA is seeking a senior professional to design end-to-end client standards and study specifications aligned with CDISC standards and regulatory guidance. You will collaborate with statisticians and programming teams to create global tools supporting CDISC-based programming needs.

This role emphasizes mentorship, training on metadata repositories, and leadership in CDISC compliance. Strong SAS skills and experience with multiple programming languages are preferred.

Qualifications

• Bachelor's degree in computer science, statistics, or a related field.
• Experience with CDISC Standards (SDTM/ADaM).
• Experience on industry teams involving CDISC, HL7, or Transcelerate.
• Strong communication skills.
• 10 years SAS programming experience or other language preferred; macro or subroutine development expected.
• Knowledge of two or more programming languages (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.

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

SAS programming

Mentoring

Communication

Team collaboration

Education

Bachelor's degree in Computer Science or Statistics

Tools

SAS

R

Python

Julia

C#

Java

Job description

IQVIA is seeking a senior professional to design end-to-end client standards and study specifications aligned with CDISC standards and regulatory guidance. You will collaborate with statisticians and programming teams to create global tools supporting CDISC-based programming needs.

This role emphasizes mentorship, training on metadata repositories, and leadership in CDISC compliance. Strong SAS skills and experience with multiple programming languages are preferred.