Jie Li

Experience

1. Associate Director, Statistical Programming

   IQVIA

   Jul 2021 — Present

   Act as an operational lead for a FSP team across multiple functional fields, including Biostatistics, Statistical Programming, Clinical Programming, Medical Writing and Commercial Support. Organize/host regular meetings with client operational leads and finance department. keep up-to-date on project issues and resource need. Create and submit monthly project budget allocation report to client. • Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resource matters. • Work with Business Department and participate in contract and contract amendment development process. • Coordinate and participate in client process improvements and implementation of revised work practices, new guidelines, and new software tools as they become available. • Manage project budget and resource requirements: understand the Scope of Work, budget and quote assumptions, estimate the work completed, and provide revenue and resource forecasts for groups of studies, integrated summaries or eSubmissions. • Serve as a Stat Programming consultant for other members of the department and staff members from other Biostatistics departments within the company. Provide advanced technical expertise for internal and external clients. • Maintain knowledge and awareness of developments in statistical programming. Provide expert review of process and methodology development work regarding SP standards and validation procedures. • Lead department training initiatives including host Training Governance monthly meetings, soliciting training presentations and planning department training sessions.

Skills

• Clinical Development
• Pharmaceutical Industry
• Cdisc
• CRO
• Statistical Programming
• Edc
• Gcp
• Sas Programming
• Sdtm
• Clinical Data Management
• Clinical Trials
• Sas
• Biostatistics
• Oracle Clinical
• Data Management