With over 30 years of experience in clinical research, biometrics, data science, data management, data analysis and visualization, and information systems, I have a comprehensive and deep knowledge of the clinical research process and the regulatory standards and best practices, from protocol to sub-mission and publication, through data collection, cleaning, and statistical analysis. I have performed or contributed to the study setup, data cleaning, data analysis and presentation, protocol and study document review, statistical programming, vendor and project management, and bring a deep and practical knowledge of ICH, 21 CFR Part 11, EUdract annex 11, SDTM and CDISC standards (CDASH, SDTM, ADaM), passed the STDM official certification in January 2021, and a member of the CDISC CORE Conformance Rules Working Group. My core values include integrity, teamwork, quality, and on-time delivery. https://scholar.google.com/citations?hl=en&user=DiQ6YWEAAAAJ https://www.linkedin.com/in/maupas/