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.
Primary Job Responsibilities
Support clients and IQVIA as an authority in the use of CDISC Standards through communication, 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 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.
Other duties as assigned
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 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 advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
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