SUMMARY: Over thirty-three years of programming experience, including over twenty-two years in Clinical Database Management programming. I have been working with CDISC SDTM compliant Datasets (utilizing SDTM v1.2 - v1.4 and SDTM IG v3.1.1 - v3.2) since the FDA began accepting them for submissions (in 2004). Vast experience annotating CRFs/eCRFs, creating Database specifications (both operational and SDTM), building data-entry applications (EDC and otherwise), and programming SAS Databases, Edit Checks, and SAS Macros. About six months experience programming, and QC of, tables and listings (no figures or graphs), and about two months experience doing QC programming of CDISC ADaM datasets.

Highlights:

• Database
• Systems Analyst
• Quality
• Quality Assurance
• Quality Control
• SAS
• Applications
• Coding
• Data Entry
• Management