Senior CDISC Standards Engineer

IQVIA; Paris; On-site; EUR 90,000 - 120,000; Full time

Job summary

IQVIA is seeking a senior professional to lead end-to-end design for client CDISC standards and study specifications in line with regulatory guidance. You will collaborate with statisticians and programmers to develop global tools supporting CDISC usage, and mentor teams on technology and systems like metadata repositories.

The role also focuses on implementing productivity tools to improve compliance, efficiency, and timely deliverables for IQVIA and clients, while ensuring submission readiness

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.
• 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.

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

SAS programming

Python

R

Communication

Mentoring

Statistical programming

Education

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

Tools

CDISC tooling

Job description

IQVIA is seeking a senior professional to lead end-to-end design for client CDISC standards and study specifications in line with regulatory guidance. You will collaborate with statisticians and programmers to develop global tools supporting CDISC usage, and mentor teams on technology and systems like metadata repositories.

The role also focuses on implementing productivity tools to improve compliance, efficiency, and timely deliverables for IQVIA and clients, while ensuring submission readiness