CDISC Standards Engineer: Regulatory Data & Automation Lead

IQVIA LLC; England; Presencial; GBP 85.000 - 110.000; Jornada completa

Descripción de la vacante

IQVIA LLC in the United Kingdom seeks an experienced CDISC/ SAS programmer to design and drive end-to-end study standards aligned with CDISC and regulatory guidance. You will collaborate with statisticians and programming teams to build global tools and ensure timely, compliant deliverables.

Experts with 10+ years in SAS or equivalent programming, CDISC knowledge, and mentoring ability are preferred. The role emphasizes governance, training, and industry leadership, with a strong focus on

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.
• 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.

Responsabilidades

• 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.

Conocimientos

SAS programming

CDISC SDTM/ADaM

Multiple languages

Strong communication

Mentoring

Educación

Bachelor's degree in CS/Statistics or related

Herramientas

SAS Macro

Metadata repositories

Descripción del empleo

IQVIA LLC in the United Kingdom seeks an experienced CDISC/ SAS programmer to design and drive end-to-end study standards aligned with CDISC and regulatory guidance. You will collaborate with statisticians and programming teams to build global tools and ensure timely, compliant deliverables.

Experts with 10+ years in SAS or equivalent programming, CDISC knowledge, and mentoring ability are preferred. The role emphasizes governance, training, and industry leadership, with a strong focus on