Greater Madrid Metropolitan Area
• More than 15 years of pharmaceutical programming • Experienced in creating SDTM and ADaM datasets and tables, listings, and figures • Programming for NDA submissions and regulatory defence • Standardization of laboratory data • Specialized in creating custom graphs
• SAS programming to create ADaM datasets and TFLs for an Integrated Summary of Safety • Created ad-hoc tables for regulatory defence and FDA Advisory Committee meeting
• SAS programming to create SDTM compliant datasets for Phase I, II and III clinical studies • Creation of SDTM Define.xml and Reviewers’ Guide • Coordinated the mapping of laboratory test terminology and unit conversions