7 дней назад
Data Standards Engineer (CDISC)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Data Standards Engineer (CDISC) (Clinical Data Standards): Designing client standards, study specifications, and productivity tools aligned with CDISC standards and regulatory guidance, with an accent on SDTM, ADaM, automation, and clinical trial data. Focus on leading standards implementation, mentoring clients and programming teams, monitoring regulatory updates, and ensuring submission compliance.
Location: Frankfurt, Hesse, Germany
Company
IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Design client standards and study specifications aligned with CDISC standards and regulatory agency guidance.
- Advise IQVIA and clients on CDISC standards through communication, collaboration, training, and mentorship.
- Partner with statisticians and programming teams to develop global tools supporting project programming needs.
- Lead productivity tool implementation to improve compliance, efficiency, and delivery timelines.
- Support metadata repositories, governance teams, standards development initiatives, and industry representation.
- Monitor regulatory and standards organizations for updates and support processes that enable CDISC compliance.
Requirements
- Bachelor's degree in computer science, statistics, or a related field.
- Experience with CDISC standards, including SDTM and ADaM.
- Experience with industry standards teams such as CDISC, HL7, or TransCelerate.
- Experience mentoring and developing others in the use of CDISC standards.
- Knowledge of at least two programming languages, such as SAS, R, Python, Julia, C#, or Java; macro or subroutine development experience is expected.
- Strong communication skills and experience with statistical programming for pharmaceutical clinical trial data; regulatory submission experience is preferred.
Culture & Benefits
- Full-time employment.
- Work focused on clinical research, healthcare intelligence, regulatory compliance, and innovative medical treatments.
- Opportunities to collaborate with clients, statisticians, programmers, governance teams, and standards organizations.
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