CDISC Standards Engineer & Tools Lead

IQVIA; Stockholms kommun; Sur place; SEK 800 000 - 1 000 000; Plein temps

Résumé du poste

IQVIA is seeking a CDISC standards specialist to develop end-to-end design of client standards and study specifications aligned to CDISC and regulatory guidance. You will support clients as an authority in CDISC norms, mentor teams, and collaborate with statisticians and programmers to build global tools.

You will drive productivity tools, governance, and industry leadership while ensuring FDA submission readiness.

Qualifications

• Bachelor’s degree in computer science, statistics, or 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.

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 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.

Connaissances

SAS programming

CDISC standards

communication skills

mentoring

macro development

Formation

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

Outils

SAS macros

Description du poste

IQVIA is seeking a CDISC standards specialist to develop end-to-end design of client standards and study specifications aligned to CDISC and regulatory guidance. You will support clients as an authority in CDISC norms, mentor teams, and collaborate with statisticians and programmers to build global tools.

You will drive productivity tools, governance, and industry leadership while ensuring FDA submission readiness.