Data Standards Engineer

IQVIA; København; On-site; DKK 800,000 - 1,100,000; Full time

Job summary

IQVIA in Copenhagen region seeks an experienced CDISC Standards Specialist to lead end-to-end design of client standards and study specifications aligned with CDISC and regulatory guidance.

You will collaborate with project statisticians and programming teams to develop global tools, mentor others, and ensure submissions meet FDA/EMEA requirements.

This role requires strong communication and knowledge of SDTM/ADaM, with a track record in pharmaceutical data.

Qualifications

• Bachelor’s degree in computer science, statistics, or a related field.
• Experience with CDISC SDTM and ADaM standards.
• Experience on industry teams involved with CDISC, HL7, or Transcelerate.
• Strong communication skills.
• 10 years SAS programming experience or equivalent.
• Knowledge of multiple programming languages (SAS, R, Python, Julia, C#, Java).
• Statistical programming experience with pharmaceutical clinical trial data.
• Experience mentoring others in CDISC standards.
• Experience in regulatory submissions is preferred.

Responsibilities

• Support clients and IQVIA as an authority in CDISC Standards through communication and mentorship.
• Collaborate with project statisticians and programming teams to develop global tools for CDISC-based programming needs.
• Lead the implementation of productivity tools to improve compliance, efficiency, and timeliness.
• Provide training and mentorship for technology and systems like metadata repositories.
• Ensure work delivered meets FDA and regulatory submission requirements.
• Guide clients in CDISC governance and standard usage.
• Monitor regulatory sites for updates and inform IQVIA leadership.
• Contribute to IQVIA initiatives as a CDISC representative.
• Interact with CDISC teams in standard development.
• Represent IQVIA as a leader in standards and automation.

Skills

CDISC SDTM

ADaM

SAS programming

Programming languages

Communication skills

Mentoring

Regulatory knowledge

Clinical trial data

Education

Bachelor's Degree in computer science or statistics

Tools

CDISC tools

Metadata repositories

SAS Studio

Job description

Reading, Berkshire, United Kingdom

Paris, France

Budapest, Hungary

Paris, France

Barcelona, Spain

Amsterdam, Netherlands

Dublin, Ireland

Madrid, Spain

Frankfurt, Hesse, Germany

Brussels, Brussels-Capital Region, Belgium

Turku, Finland

Athens, Greece

Copenhagen, Denmark

Stockholm, Sweden

Full time

R1573235

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 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.

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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