CDISC Standards Engineer — Global Data Compliance Lead

IQVIA; Turku; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

IQVIA is seeking a senior professional to lead end-to-end design of client standards and study specifications aligned with CDISC standards. The role collaborates with statisticians and programming teams to develop global tools, and guides clients in CDISC governance and regulatory submissions.

Responsibilities include training, mentorship, and developing productivity tools to improve compliance and timeliness of deliverables, with a focus on using metadata repositories to support IQVIA and

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 with standards such as CDISC, HL7, or Transcelerate.
• Strong communication skills.
• 10+ years SAS programming experience or other related programming language experience preferred; macro/subroutine development expected.
• Knowledge of 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 mentoring and developing others in the use of CDISC standards.
• Experience in submissions to regulatory authority preferred.

Responsabilités

• 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 supporting CDISC standards.
• Lead the implementation of productivity tools to improve compliance, efficiencies, and timeliness of deliverables.
• Provide training and mentorship for the use of technology and systems, such as metadata repositories.
• Ensure work delivered to clients meets minimum submission requirements per FDA and other regulatory guidance.
• Guide clients in their use of CDISC standards through governance teams.
• Monitor regulatory authority sites for updates and inform IQVIA leadership.
• Work on other IQVIA initiatives as a CDISC representative.
• Interact with CDISC-sanctioned teams in development of standards.
• Represent IQVIA as a leader in Standards and Automation.
• Support leadership in developing processes and tools enabling CDISC compliance.

Connaissances

Strong communication

SAS programming

Mentoring others

Regulatory submissions

Formation

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

Outils

SAS

R

Python

Java

C#

Julia

Description du poste

IQVIA is seeking a senior professional to lead end-to-end design of client standards and study specifications aligned with CDISC standards. The role collaborates with statisticians and programming teams to develop global tools, and guides clients in CDISC governance and regulatory submissions.

Responsibilities include training, mentorship, and developing productivity tools to improve compliance and timeliness of deliverables, with a focus on using metadata repositories to support IQVIA and