Description
SUMMARY: Industry-experienced statistical and programming consultant with hands-on knowledge of current clinical systems technologies and global regulatory submission standards. Senior team leader and key member of clinical programming, project management, and clinical and statistical reporting system development teams. Proven record of working effectively to deliver validated, submission quality, clinical data, supporting tables, and computer systems to summarize and report clinical findings to International regulatory authorities. Advanced SAS developer. Automatically generate draft patient narratives embedding clinical data in Word document. Multiple SAS based report generation systems. CDISC - SDTM and ADaM standards definition and clinical data mapping.