Teams at Syneos Health

Leads statistical programming activities across complex clinical studies, developing and validating SAS or R programs for SDTM, ADaM, TLFs, tables, listings, figures, and derived datasets. Reviews specifications and clinical study documentation, ensures CDISC and regulatory compliance, manages concurrent deliverables, mentors programmers, supports sponsor meetings, and provides technical expertise in oncology endpoints, submissions, and programming standards.

Leads statistical programming for clinical trials, using SAS to create and validate tables, listings, graphs, derived datasets, and study outputs. Reviews specifications and analysis plans, ensures quality and inspection readiness, resolves discrepancies, manages timelines across projects, and directs programming deliverables. Participates in sponsor meetings, mentors programmers, develops training, and supports regulatory-compliant documentation and processes.

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.