IQVIA өмір туралы ғылымдар және денсаулық сақтау салаларындағы ұйымдарға күрделі мәселелерді шешуге көмектесу үшін денсаулық сақтау деректерінің аналитикасын, озық технологиялар мен консалтингті біріктіреді. Оның Connected Intelligence платформасы клиникалық зерттеулерді, технологияларды әзірлеуді және жаңа емдеу әдістерін дамытуға қолдау көрсету үшін деректер мен жасанды интеллектіні біріктіреді. Компанияның командалары аналитика, консалтинг және денсаулық сақтау технологиясы бағыттарында жұмыс істеп, зерттеулерге, цифрлық инновацияларға және пациенттердің нәтижелерін жақсартуға бағытталған бастамаларға байланысты мүмкіндіктер ұсынады.
Senior CDISC Data Standards Engineer
Apply CDISC standards, regulatory guidance, and automation tools at IQVIA. Support clinical research clients and global programming teams through submissions, training, and standards implementation.
Сипаттама
- Advise clients and IQVIA teams on applying CDISC standards through collaboration, training, and mentorship.
- Work with statisticians and programming teams to build global tools for project programming and CDISC implementation.
- Lead the rollout of productivity tools that strengthen compliance and improve delivery efficiency and timeliness.
- Train and mentor colleagues on technology and systems, including metadata repositories.
- Check client work against FDA submission requirements and other applicable regulatory guidance.
- Help clients interpret and apply CDISC standards through governance teams.
- Track updates from regulatory authorities and standards organizations, and share relevant changes with leadership.
- Represent CDISC standards in IQVIA initiatives.
- Take part in CDISC and other relevant industry standards groups and initiatives.
- Represent IQVIA in the industry on standards and automation.
- Help leadership develop and continually improve CDISC compliance processes and tools.
Талаптар
- Bachelor’s degree in Computer Science, Statistics, Life Sciences, or a related discipline.
- Extensive knowledge of and experience applying CDISC standards.
- At least 7 years of SDTM experience.
- At least 5 years of ADaM experience.
- CDASH experience is desirable.
- Experience contributing to standards initiatives or working groups such as CDISC, HL7, TransCelerate, PHUSE, or similar organizations.
- Strong analytical and problem-solving abilities.
- Careful, accurate, consistent work that meets quality standards and applicable regulatory requirements.
- Strong communication, collaboration, and negotiation skills.
- Ability to assess study-specific needs and develop practical solutions that comply with standards.
- Ability to work independently and exercise sound judgment.
- Ability to balance multiple priorities and work effectively with cross-functional, global teams.
- More than 6 years of SAS programming experience is preferred.
- R or Python experience is advantageous.
- Experience mentoring and developing others in CDISC standards.
- Experience supporting regulatory authority submissions is preferred.
- Demonstrated interest and active participation in standards-related activities.