[天津|中山]天津杰纳医药科技发展有限公司

岗位职责：

• Develop programs to produce SDTM and ADaM datasets, based on CDISC standards
• Develop programs to produce tables, listings, figures and other ad hoc analysis report
• Prepare FDA submission documents, including annotated CRF, define.xml, reviewer’s guide, CSR, etc.
• Participate in data management activities, including CRF design, EDC system set up, UAT, and so on.
• Medical coding with MedDRA and WHODrug dictionary
• SAE reconciliation
• Prepare DSUR, Clinical Data Management report, Data Management Plan, and Data Validation Plan.
• Develop SAS macros
• Online meeting with client at flexible time

任职要求:

·     
本科及本科以上学历

·     了解新药临床试验I~IV期的整个过程及ICH-GCP规范

·      对数据感兴趣，具有医学，数学，统计，或计算机相关知识背景

·      有SAS编程经验，通过了SAS Base及SAS Advance认证的优先给予考虑

·      对CDISC规范了解也会获得加分

·       英语六级水平，口语流利，并且能够和国外客户用邮件和电话无障碍交流

·       认真，细心，吃苦耐劳，踏实稳重，有高度的责任心和团队合作精神