Data Standards Engineer

IQVIA LLC; Reading; Hybride; GBP 70 000 - 100 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

CDISC SDTM/ADaM

SAS programming

Multiple languages (SAS, R, Python, Py

Regulatory submissions knowledge

Mentoring & training

Strong communication skills

Formation

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

Outils

SAS

R

Python

Java

C#

Julia

Description du poste

**Job Summary:**This position is responsible for the development of the end-to-end design of client standards and study specifications that align to the CDISC standards and regulatory agency guidance’s. **Job Responsibilities:**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.**Minimum Requirements:**Bachelor's Degree in computer science, statistics, or a related area Experience with CDISC Standards, specifically SDTM and ADaM Experience on industry team 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 preferredIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.