IQVIA
Data Standards Engineer (CDISC)
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Job Summary
This position is responsible for the development of the end-to-end design of client standards and study specifications that align with the CDISC standards and regulatory agency guidance's. This position provides this guidance and training to clients of IQVIA.
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.
- Assure that work delivered to clients meets minimum submission requirements as defined by FDA Guidance Documents and other regulatory guidance.
- Guide clients in their use of CDISC standards through governance teams.
- Monitor regulatory authority and standards organization sites for updates and inform 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.
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Minimum Requirements
- Bachelor's Degree in computer science, statistics, or a related area.
- Experience with CDISC Standards, specifically SDTM and ADaM.
- Experience on an industry team involved in standards such as CDISC, HL7, or Transcelerate.
- Strong communication skills.
- 10 years of 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.
About IQVIA
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
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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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