Marcelina Hungria is an owner of DIcore Group, a CDISC Gold Member. As a consultant, supports clients with Metadata Repository (MDR) development, CDISC Standards Implementation and Data Submission services.
She has a BS in Computer Science and an MBA from Rutgers University. She has extensive experience developing and validating software tools, plus overall system testing. Expertise in SAS and other programming languages.
Marcelina has been working in the pharma/biotech industry for nearly 30 years, and for the last 20 has been focusing on preparation of SDTM and ADaM-based data and results, plus validation of regulatory submissions and metadata management systems in connection with implementation of most CDISC Standards. Overall, helping sponsors to plan, collect, integrate, validate and improve the quality of data for multiple uses, building software tools to provide traceability and impact analysis from planning to analysis results. She has been involved in the development and testing of the CDISC Library metadata, contributing to curate content for CDASH, SDTM and Controlled Terminology, and performing API testing.
Marcelina has been a CDISC volunteer since 2008, active participant on the CDISC Data-Exchange (former CDISC XML Technologies), SDTM and SDTMIG development teams, core team member in the ODM 2.1, Define-XML 2.x, Dataset-JSON 1.x Standards, plus diverse SDTM and SDTMIG versions and the MSG 2.0 development efforts, and more recently active contributor on the CDISC CORE initiative. She is also contributing on the CDISC ODM Certification Program.
Previous contributions to PhUSE/FDA WG's include deliverables related to Metadata, Traceability and Analysis Results projects plus the Define-XML 2.0 / Implementation Guidelines.