Data Standards Engineer

h3Job Summary /h3 pThis 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. /p h3Job Responsibilities /h3 ul liSupport clients and IQVIA as an authority in the use of CDISC Standards through communication, collaboration, training, and mentorship. /li liPartner with project statisticians and programming teams to develop global tools to support project programming needs in the use of CDISC Standards /li liLead the implementation of productivity tools for IQVIA and clients which improve compliance, efficiencies, and timeliness of deliverables to clients. /li liProvide training and mentorship for the use of technology and systems, such as metadata repositories, to support IQVIA and client's in their use. /li liAssures that work delivered to clients meet minimum submission requirements as defined by FDA Guidance Documents and other regulatory guidance. /li liGuide clients in their use of CDISC standards through governance teams. /li liMonitors regulatory authority and standards organization sites for updates and informs IQVIA leadership of updates. /li liWork on other IQVIA initiatives as a CDISC representative. /li liInteract with various CDISC sanctioned teams in the development of standards. /li liRepresent IQVIA in the industry as a leader in the use of Standards and Automation /li liSupport leadership in the development of processes and tools which enable CDISC compliance. /li /ul h3Minimum Requirements /h3 ul liBachelor's Degree in computer science, statistics, or a related area /li liExperience with CDISC Standards, specifically SDTM and ADaM /li liExperience on industry team involved in standards such as CDISC, HL7, or Transcelerate. /li liStrong communication skills /li li10 years SAS programming experience or other related programming language experience preferred. Knowledge of macro or subroutine development is expected. /li liKnowledge and experience in two or more programming languages such as SAS, R, Python, Julia, C#, Java, or other language /li liRelevant statistical programming experience with pharmaceutical clinical trial data preferred /li liExperience in mentoring and developing others in the use of CDISC standards /li liExperience in submissions to regulatory authority preferred /li /ul pIQVIA 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 /p pIQVIA 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. /p