Data Standards Engineer

IQVIA Holdings Inc.; Reading; On-site; GBP 70,000 - 110,000; Full time

Job summary

IQVIA Holdings Inc. in Reading, United Kingdom, seeks a CDISC Standards Specialist to shape end-to-end design and study specifications aligned to CDISC standards and regulatory guidance.

You will collaborate with statisticians and programming teams to develop global tools, lead productivity improvements, and mentor clients on governance and regulatory updates while ensuring high-quality submissions.

Qualifications

• Bachelor's Degree in computer science, statistics, or related area.
• CDISC Standards experience, 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; macro/subroutine knowledge.
• Proficiency in SAS, R, Python, Julia, C#, Java, or similar languages.
• Relevant statistical programming experience with pharmaceutical clinical trial data.
• Experience in mentoring and developing others in CDISC standards.
• Experience in submissions to regulatory authority.

Responsibilities

• Design end-to-end client standards and study specifications aligned to CDISC standards and regulatory guidance.
• Partner with project statisticians and programming teams to develop global tools for CDISC programming needs.
• Lead implementation of productivity tools to improve compliance, efficiencies, and timeliness of deliverables.
• Provide training and mentorship for the use of technology and systems including metadata repositories.
• Ensure work delivered meets FDA submission requirements and other regulatory guidance.
• Guide clients in their use of CDISC standards through governance teams.

Skills

Strong communication

Mentoring

Regulatory submissions

Education

Bachelor's degree in CS/Stats/related

Tools

SAS

R

Python

Java

Job description

• 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., 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.

• 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 preferred

IQVIA 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.com

IQVIA 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.