职位信息
岗位职责：
1. 负责制定统计分析计划，包括统计方法、主要统计程序、定义衍生变量、数据处理原则以及统计表格式样；
2. 对统计相关文档，如临床研究方案、统计分析计划、统计分析图表、统计报告、临床研究报告等，进行独立的同行评审或质量控制；
3. 协助样本量计算、临床研究方案和病例报告表（CRF）的评审；
4. 准备随机化规范并验证随机化的规范及明细，提供与准备、分发和获取随机化以及揭盲信息等相关活动的支持；
5. 就数据库设计向数据管理部门提供建议，并负责关键数据及其质量的审查；
6. 要求合同研究组织（CRO）或其他合作伙伴对其产品的高质量标准负责。
Responsibilities：
1. Responsible for the development of statistical analysis plans, including statistical methods, main statistical procedures, definition of derived variables, data processing principles and statistical table format;
2. Independent peer review or quality control of statistical documents, such as clinical research protocols, statistical analysis plans, statistical analysis charts, statistical reports and clinical research reports;
3. Assisted in sample size calculation, clinical research protocol and case report form (CRF) review;
4. Prepare and verify the randomization specifications and details, and provide support for activities related to preparation, distribution and acquisition of randomization and unblinding information;
5. Provide advice on database design to the data management department and be responsible for the review of key data and its quality;
6. Hold contract Research Organizations (CRO) or other partners accountable for the high quality standards of their products.
任职要求：
1. 掌握生物统计领域知识；
2. 运用统计专业知识解决临床研究的相关问题；
3. 熟练使用一种或多种统计分析软件，如SAS, R, S-Plus, MATLAB等；
4. 熟悉临床数据交换标准（CDISC）及相关的知识，并能执行相应的数据分析；
5. 能独立查阅有关文献资料，撰写各类报告；
6. 了解《药品管理法》、《新药审批办法》，熟悉ICH-GCP，熟悉药物研发的全过程，精通临床试验全过程，熟悉国内外临床研究发展与现状；
7. 具有清晰地书面和口头表达能力，善于进行活跃而积极地沟通；
8. 具有独立工作能力，但同时又具有较强的集体意识和良好的团队合作精神；
9. 具有良好的适应能力，能在时间限制和任务压力下工作；
10. 热爱并看好本行业，有良好的职业道德和奉献精神。
Requirements：
1. Master knowledge in the field of biostatistics;
2. Use statistical expertise to solve problems related to clinical research;
3. Proficient in one or more statistical analysis software, such as SAS, R, S-Plus, MATLAB, etc.;
4. Familiar with clinical data Exchange standards (CDISC) and related knowledge, and able to perform corresponding data analysis;
5. Can independently consult relevant literature and write various reports;
6. Familiar with drug Administration Law and New Drug Approval Methods, familiar with icH-GCP, the whole process of drug r&d, proficient in the whole process of clinical trial, and familiar with the development and status quo of clinical research at home and abroad;
7. Have clear written and oral expression ability, good at active and active communication;
8. Able to work independently, but with strong collective consciousness and good team spirit;
9. Good adaptability, able to work under time limitation and task pressure;
10. Love and optimistic about the industry, with good work ethic and dedication.
