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У роли понятный фокус на стандартах CDISC, регуляторном соответствии и автоматизации в крупной компании из сферы клинических исследований. Зарплата не указана, поэтому сопоставить предложение с рыночным ориентиром нельзя.
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Зарплата не указанаАктуальные технологииПонятная рольВклад в медицину
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Описание вакансии
Текст:
Hirify AI/Оригинал
TL;DR
Data Standards Engineer (CDISC): Designing client standards and study specifications aligned with CDISC standards and regulatory guidance with an accent on SDTM, ADaM, automation, and clinical trial data. Focus on developing productivity tools, supporting regulatory submissions, mentoring teams, and guiding clients through standards governance and compliance.
Location: Reading, Berkshire, United Kingdom
Company
IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
Design end-to-end client standards and study specifications aligned with CDISC standards and regulatory agency guidance.
Support clients and internal teams as an authority on CDISC standards through communication, collaboration, training, and mentorship.
Partner with statisticians and programming teams to develop global tools supporting project programming and CDISC compliance.
Lead the implementation of productivity tools that improve compliance, efficiency, and delivery timelines.
Monitor regulatory and standards organization updates and represent IQVIA in CDISC and industry initiatives.
Support governance processes, metadata repository use, and regulatory submission readiness.
Requirements
Bachelor's degree in computer science, statistics, or a related field.
Experience with CDISC standards, specifically SDTM and ADaM.
Experience participating in standards organizations or industry teams such as CDISC, HL7, or TransCelerate.
Strong communication skills and experience mentoring others in the use of CDISC standards.
Knowledge of two or more programming languages, such as SAS, R, Python, Julia, C#, or Java; macro or subroutine development knowledge is expected.
Approximately 10 years of SAS or related programming experience, with relevant statistical programming experience in pharmaceutical clinical trial data.
Nice to have
Experience with submissions to regulatory authorities.
Culture & Benefits
Work on initiatives supporting clinical research, healthcare intelligence, and the development of medical treatments.
Collaborate with clients, statisticians, programmers, leadership, governance teams, and standards organizations.
Contribute to industry standards, automation, and tools that improve compliance and delivery quality.
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