CDISC Standards Engineer: Drive Global Data Standards & Automation

IQVIA; København; Vor Ort; DKK 800.000 - 1.100.000; Vollzeit

Zusammenfassung

IQVIA in Copenhagen region seeks an experienced CDISC Standards Specialist to lead end-to-end design of client standards and study specifications aligned with CDISC and regulatory guidance.

You will collaborate with project statisticians and programming teams to develop global tools, mentor others, and ensure submissions meet FDA/EMEA requirements.

This role requires strong communication and knowledge of SDTM/ADaM, with a track record in pharmaceutical data.

Qualifikationen

• Bachelor’s degree in computer science, statistics, or a related field.
• Experience with CDISC SDTM and ADaM standards.
• Experience on industry teams involved with CDISC, HL7, or Transcelerate.
• Strong communication skills.
• 10 years SAS programming experience or equivalent.
• Knowledge of multiple programming languages (SAS, R, Python, Julia, C#, Java).
• Statistical programming experience with pharmaceutical clinical trial data.
• Experience mentoring others in CDISC standards.
• Experience in regulatory submissions is preferred.

Aufgaben

• Support clients and IQVIA as an authority in CDISC Standards through communication and mentorship.
• Collaborate with project statisticians and programming teams to develop global tools for CDISC-based programming needs.
• Lead the implementation of productivity tools to improve compliance, efficiency, and timeliness.
• Provide training and mentorship for technology and systems like metadata repositories.
• Ensure work delivered meets FDA and regulatory submission requirements.
• Guide clients in CDISC governance and standard usage.
• Monitor regulatory sites for updates and inform IQVIA leadership.
• Contribute to IQVIA initiatives as a CDISC representative.
• Interact with CDISC teams in standard development.
• Represent IQVIA as a leader in standards and automation.

Kenntnisse

CDISC SDTM

ADaM

SAS programming

Programming languages

Communication skills

Mentoring

Regulatory knowledge

Clinical trial data

Ausbildung

Bachelor's Degree in computer science or statistics

Tools

CDISC tools

Metadata repositories

SAS Studio

Jobbeschreibung

IQVIA in Copenhagen region seeks an experienced CDISC Standards Specialist to lead end-to-end design of client standards and study specifications aligned with CDISC and regulatory guidance.

You will collaborate with project statisticians and programming teams to develop global tools, mentor others, and ensure submissions meet FDA/EMEA requirements.

This role requires strong communication and knowledge of SDTM/ADaM, with a track record in pharmaceutical data.