Colleen has been with Nuventra since May of 2018 and demonstrates her abilities in data management, manipulation, and visualization through statistical programming in R, primarily for Noncompartmental Analyses. She specializes in all SDTM and ADaM CDISC dataset generation and FDA data standards. Colleen is active with the CDISC organization, participating in two separate volunteer teams to aid in developing and continuously improving data standards. Colleen also has experience constructing define.xml files and other programming items that ultimately go into a final data package for full clinical submissions. In addition, she has basic clinical operations experience, including database setup and maintenance, as well as involvement in authoring and coordinating data transfer process documents to ensure efficient and secure data transfer.