Standards Engineer

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Join to apply for the Standards Engineer role at IQVIA . This position is responsible for the development of end-to-end design of client standards and study specifications that align with CDISC standards and regulatory agency guidance. It also involves providing guidance and training to IQVIA clients. Job Summary: Responsible for designing client standards and study specifications aligned with CDISC standards and regulatory guidance, and providing training to clients. Job Responsibilities: Support clients and IQVIA as an authority in 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, efficiency, and timeliness. Provide training and mentorship on technology and systems, such as metadata repositories. Ensure work meets minimum submission requirements per FDA and other regulatory guidance. Guide clients in using CDISC standards via governance teams. Monitor regulatory updates and inform IQVIA leadership. Participate in IQVIA initiatives as a CDISC representative. Collaborate with CDISC sanctioned teams in standards development. Represent IQVIA as a leader in standards and automation in the industry. Support leadership in developing processes and tools for CDISC compliance. Minimum Requirements: Bachelor's Degree in computer science, statistics, or related field. Experience with CDISC Standards, especially SDTM and ADaM. Experience on industry standards teams (CDISC, HL7, Transcelerate). Strong communication skills. 10+ years SAS programming or similar experience; macro/subroutine development skills. Proficiency in two or more programming languages (SAS, R, Python, Julia, C#, Java). Relevant statistical programming experience in pharmaceutical clinical trials preferred. Experience mentoring others in CDISC standards. Regulatory submission experience preferred. IQVIA is a leading provider of clinical research services, insights, and healthcare intelligence. We are committed to diversity and equal opportunity. Learn more at https://jobs.iqvia.com and https://jobs.iqvia.com/eoe . The estimated annual base pay range is $98,200 - $273,200, with actual offers varying based on qualifications, location, and other factors. Additional incentives and benefits may apply. Additional Details: Seniority level: Not Applicable Employment type: Full-time Job function: Engineering and IT Industry: Pharmaceutical Manufacturing Apply now or set job alerts for similar roles.
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Location:
Boston, MA, United States
Salary:
$200,000 - $250,000
Job Type:
FullTime
Category:
Engineering

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