James Gaiser

Mr. James Gaiser, Associate Director, Statistical Programming, has over 30 years of experience in statistical programming and analysis in the biopharmaceutical industry. At PROMETRIKA, Mr. Gaiser manages the Statistical Programmers, which are responsible for all SAS® programming activities required for phase 1 through 4 clinical trials and regulatory submissions. He is an active member of the CDISC ADaM team and participates in PhUSE committees as time permits.

Prior to joining PROMETRIKA, Mr. Gaiser was Director of Statistical Programming at EMD Serono, where he led a global group of statistical programmers across multiple therapeutic areas. He planned and managed programming support for clinical trials, regulatory requests, communication and publication needs, and marketing objectives. Mr. Gaiser was a member of the internal teams that developed methods for converting studies to CDISC specifications. His responsibilities included setting up ADaM analysis dataset templates, review of study analysis datasets for CDISC compliance, and participating in SDTM creation.

Prior to EMD Serono, Mr. Gaiser held Principal Analyst and Manager positions at Bristol‑Myers Squibb. Within these positions, he was responsible for the successful implementation of all programming activities for numerous product reports and submissions. His work supported Independent Data Safety Monitoring Committees, Biologic Licensing Applications, Periodic Safety Update Reports, FDA Advisory Committee Briefing Documents, responses to FDA inquiries, and many international regulatory submissions.

Mr. Gaiser received his Bachelor of Science degree in Biomedical Computing from Rochester Institute of Technology in 1987.