Teams at Worldwide Clinical Trials

Lead statistical design, analysis and reporting for clinical trials. Develop and validate SAS programs, produce SDTM/ADaM datasets, tables/figures/listings, write SAPs and reports, advise on study design, ensure regulatory compliance, and manage statistics support for sponsor projects.

Manage and deliver site activation activities for clinical studies including site identification, document collection, EC/IRB coordination, contract monitoring, project planning, risk mitigation, metrics reporting, SOP contribution, and sponsor communication to meet GCP and regulatory requirements.

Manage planned and unplanned Quality Management Document deviations, maintain QMS trackers and electronic tools, deliver and support QMS training, analyze deviation trends and KPIs, and report findings to governance. Support external dissemination of QMS records and provide stakeholder and audit/inspection support as needed.