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1) Ensure timely and quality development and validation of low-medium complexity datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/project
2) Interact and communicate with Statisticians, Data Mangers, Clinical Operations, Medical Monitors and Medical Writers to develop and validation of customized outputs
3) Comply with company, department and industry guidelines, Maintain supporting documentation for studies to ensure traceability and regulatory compliance
4) Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents
5) Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results
专业培训 五险一金 补充医疗保险 餐饮补贴 交通补贴 绩效奖金 年终奖金 定期体检
