CDISC Standards Engineer | Data Governance & Tools

IQVIA; Brussel Hoofdstad; Presencial; EUR 90.000 - 150.000; Jornada completa

Descripción de la vacante

IQVIA seeks a seasoned professional to design end-to-end CDISC standards and study specifications aligned to regulatory guidance. You will mentor teams, collaborate with statisticians and programming teams, and lead tool implementations to enhance compliance and efficiency.

The role emphasizes governance, training, and staying current with FDA guidance and industry standards to support IQVIA and clients worldwide.

Formación

• 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; macro/subroutine development expected.
• Knowledge of two or more programming languages (SAS, R, Python, Julia, C#, Java)
• 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.

Responsabilidades

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

Conocimientos

Strong communication

CDISC SDTM/ADaM

Regulatory submissions experience

Mentoring

FDA/regulatory knowledge

Programming language proficiency

Educación

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

Herramientas

SAS

R

Python

Julia

C#

Java

Descripción del empleo

IQVIA seeks a seasoned professional to design end-to-end CDISC standards and study specifications aligned to regulatory guidance. You will mentor teams, collaborate with statisticians and programming teams, and lead tool implementations to enhance compliance and efficiency.

The role emphasizes governance, training, and staying current with FDA guidance and industry standards to support IQVIA and clients worldwide.