Lisa Lin

Lisa Lin is a Study Data Standards Manager at FDA CBER (Center for Biologics Evaluation and Research). Currently she is responsible for all study data standards projects in CBER, including study data validation, evaluation and testing of the SEND standard for CBER, data standards and analysis tool training and support for CBER reviewers.

Before joining CBER, Lisa worked at CDER (Center of Drug Evaluation and Research) as a Data Standards Lead. She played an important role of leading CDER on study data standards development and implementation and her contribution includes the Development of Technical Rejection Criteria, Technical Conformance Guide, FDA Business Rules, FDA Data Standards Catalog, various technical specification guides, eData mailbox, training and support of analysis tools, consultation on Pre-NDA/Pre-BLA/IND meetings. Before joining FDA, Lisa contributed extensive experience and strong technical background working on CDISC data standards and clinical trial data analysis and submissions in several pharmaceutical companies. She received her MBA from West Chester University.