Statistical Programmer II

该职位是精鼎医药（Parexel）的统计程序员，主要负责临床试验数据的统计编程工作，包括生成SDTM/ADaM数据集、表格、图表和列表，并协助项目启动和文档管理

Key Accountabilities: Project Management: Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Statistical Programming for Assigned Projects: Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings. Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation. Training: Maintain and expand local and international regulatory knowledge within the clinical industry. Develop knowledge of SAS and processes/procedures within other Parexel functional areas. Provide relevant training and mentorship to staff and project teams as appropriate. General: Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulator compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in process/quality improvement initiatives. Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).