Principal Biostatistician

该职位为精鼎医药的 Principal Biostatistician，负责临床试验的统计设计、分析和报告，需为 DMC 提供独立统计支持，并参与业务拓展

Key Accountabilities : Operational Execution Provide broad statistical support, including trial design, protocol and CRF development on specific studies Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review Business Development Support of Business Development, by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings General Activities Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis Understand, apply and provide training in extremely advanced and sometimes novel statistical methods Contribute to the development and delivery of internal and external statistical training seminars and courses Review position papers based on current good statistical practice Interact with clients and regulatory authorities Review publications and clinical study reports Travel to, attend, and actively contribute to all kind of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results) Additional responsibilities as defined by supervisor/manager.

The knowledge of pharmacokinetic data is an advantage