Data Standards Engineer (CDISC)
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. 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.
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. 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.