Data Standards Engineer

IQVIA; Turku; On-site; EUR 70,000 - 110,000; Full time

Job summary

IQVIA is seeking a senior professional to lead end-to-end design of client standards and study specifications aligned with CDISC standards. The role collaborates with statisticians and programming teams to develop global tools, and guides clients in CDISC governance and regulatory submissions.

Responsibilities include training, mentorship, and developing productivity tools to improve compliance and timeliness of deliverables, with a focus on using metadata repositories to support IQVIA and

Qualifications

• Bachelor's Degree in computer science, statistics, or a related area.
• Experience with CDISC Standards, specifically SDTM and ADaM.
• Experience on industry teams involved with standards such as CDISC, HL7, or Transcelerate.
• Strong communication skills.
• 10+ years SAS programming experience or other related programming language experience preferred; macro/subroutine development expected.
• Knowledge of 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 mentoring and developing others in the use of CDISC standards.
• Experience in submissions to regulatory authority preferred.

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 supporting CDISC standards.
• Lead the implementation of productivity tools to improve compliance, efficiencies, and timeliness of deliverables.
• Provide training and mentorship for the use of technology and systems, such as metadata repositories.
• Ensure work delivered to clients meets minimum submission requirements per FDA and other regulatory guidance.
• Guide clients in their use of CDISC standards through governance teams.
• Monitor regulatory authority sites for updates and inform IQVIA leadership.
• Work on other IQVIA initiatives as a CDISC representative.
• Interact with CDISC-sanctioned teams in development of standards.
• Represent IQVIA as a leader in Standards and Automation.
• Support leadership in developing processes and tools enabling CDISC compliance.

Skills

Strong communication

SAS programming

Mentoring others

Regulatory submissions

Education

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

Tools

SAS

R

Python

Java

C#

Julia

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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