CDISC Standards Engineer & Automation Lead

IQVIA LLC; Reading; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

IQVIA in Reading, United Kingdom, is seeking a senior statistician/programmer to develop end-to-end CDISC standards and study specifications that align with FDA guidance. You will work with project statisticians and programming teams to build global tools and lead productivity initiatives in CDISC compliance.

The role emphasizes mentoring others, governance of CDISC standards, and staying current with regulatory updates, with responsibilities spanning client collaboration, training, and industry

Qualifications

• Bachelor's degree in computer science, statistics, or a related area.
• 10 years SAS programming experience or other related language preferred.
• Knowledge of macro or subroutine development.
• Experience in two or more programming languages such as SAS, R, Python, Julia, C#, Java, or other language.
• Experience with CDISC Standards, specifically SDTM and ADaM.
• Experience on industry teams involved in standards such as CDISC, HL7, or TransCelerate.
• Experience in submissions to regulatory authority preferred.
• Strong communication skills.
• Experience in mentoring and developing others in the use of CDISC standards.

Responsibilities

• Develop end-to-end design of client standards and study specifications aligned to CDISC standards.
• Support clients and IQVIA 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.

Skills

CDISC SDTM/ADaM

SAS programming

Multiple languages (SAS, R, Python, Py

Regulatory submissions knowledge

Mentoring & training

Strong communication skills

Education

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

Tools

SAS

R

Python

Java

C#

Julia

Job description

IQVIA in Reading, United Kingdom, is seeking a senior statistician/programmer to develop end-to-end CDISC standards and study specifications that align with FDA guidance. You will work with project statisticians and programming teams to build global tools and lead productivity initiatives in CDISC compliance.

The role emphasizes mentoring others, governance of CDISC standards, and staying current with regulatory updates, with responsibilities spanning client collaboration, training, and industry