Teams at Syneos Health

Develops and advises on risk-based central monitoring strategies for clinical studies. The role leads risk assessments, supports Risk Assessment Categorization Tool processes, evaluates centralized statistical monitoring and data-quality risks, defines quality tolerance limits, and facilitates cross-functional and sponsor reviews. It also provides training, mentoring, inspection-readiness support, budget and scope oversight, risk escalation, and occasional business-development assistance while ensuring compliance with ICH/GCP, protocol, country regulations, and applicable good pharmacoepidemiology practices.

Leads clinical statistical programming across multiple complex projects using SAS to create and validate ADaM datasets, tables, listings, and figures. Develops specifications, ensures CDISC and regulatory compliance, reviews clinical documentation, manages timelines, and supports inspection readiness. Serves as the lead programmer and technical expert, directing programming teams, mentoring staff, contributing to tools and SOPs, and participating in sponsor and bid defense meetings.

Leads statistical programming for clinical trials, developing and validating SAS outputs, datasets, tables, listings, and figures across safety and efficacy data. Creates specifications, ensures CDISC compliance, maintains inspection-ready documentation, manages concurrent deliverables, mentors programmers, supports sponsor meetings, and provides technical expertise in SDTM, ADaM, TLF, ISS, ISE, and regulatory submission requirements.