Senior Statistical Programmer

Supports statistical programming activities for clinical studies, submissions, and development initiatives. Contributes to timelines and work product required to deliver high quality statistical programming services. Maintains a basic understanding of relevant industry trends in standards implementation and clinical statistical programming. Supports the development and rollout of new innovations, standards, processes, and programming efficiencies within Biostatistics. Supports collaboration with Data Management on database standards to facilitate SDTM development. Ensures that statistical deliverables (tables, figures, listings) and study datasets (SDTM, ADaM) are validated and meet standards requirements of regulatory agencies, Sponsors, and Lexitas Assesses study datasets and resolves deviations from CDISC using Pinnacle21 or other quality tools. Develops specification documents for all datasets, and other supporting documents such as define.xml, annotated CRFs, and reviewer’s guides. Programs, validates, maintains, and documents statistical analysis programs for deliverables outlined in the statistical analysis plan or other documents following Lexitas standard operating procedures. Develops programming efficiencies to ensure a productive work environment producing deliverables of high quality. Mentor’s junior statistical programmers in programming methodologies. recblid d7bjdczq34pbh16byc0ncwptxw68dd