统计师岗位职责

岗位职责: This position provides statistical support to development clinical research projects; interacts with research personnel to ascertain needs develops appropriate design statistical solutions. Develops/Coordinates statistical analysis plans (SAPs) statistical reports fuse by internal external customers. Monitors work to ensure quality, continuously promote Quality First Time ensures compliance with the company SOPs, Policies, Directives, Divisional standards, Declaration of Helsinki, Industry standards, relevant GxPs, both CNMPA and/international requirements and/best practices. 1. Interact with product developers clinical investigators to design clinical trials with appropriate statistical methods adequate sample size fstatistical justification of clinical utility claims. 2. Write data analysis plans as needed to capture design elements statistical methodology. 3. Perform/Support data analysis prepares statistical reports of results. 4. Perform Quality Control (QC) fstatistical analyses to ensure analysis quality. 5. Conduct randomization blinding of samples, if apply. 6. Maintain expertise in state-of-the-art data manipulation statistical analyses. 7. Manage technical aspects of project(s), as assigned. 8. Monitwork to ensure quality, continuously promotes Quality First Time. 9. If apply, be a contact window, develop maintain a good working relationship with BAs other dept. to support the cross-functional projects 10. Other projects tasks assigned by line manager 11. Conduct business in full compliance including but not limited to Roche Secure, Roche Behaviin Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health Environmental Protection 任职要求: 1. At least Master degree in Statistics a related field, at least 3 years of relevant experience 2. Proficiency in English language skills 3. Good commof SAS other statistical software 4. Understpharmaceutical and/medical device regulation ICH/GCP 职位福利：五险一金、年底双薪、绩效奖金、餐补、带薪年假、补充医疗保险、通讯补助、定期体检

岗位职责：
临床试验方案设计
样本量计算
随机化管理
统计分析计划撰写
制作统计相关图标
统计分析报告撰写
参与数据审核会议
统计分析人群划分
任职要求：
3年以上生物统计师相关工作经验， 硕士以上学历，生物统计，流行病学，公共卫生，数理统计等相关专业。
熟悉临床试验全部流程，熟悉临床试验设计及统计分析流程，能够独立进行统计相关工作。
能熟练使用SAS, R等统计分析工具。
独立撰写统计分析计划及统计分析报告，对法规相关要求有一定理解。良好的沟通能力。

临床统计师职位描述：工作职责：1负责临床研究项目在方案设计过程中的数据统计工作；2临床医学数据的整理、按要求进行分析；3独立撰写统计分析计划，统计分析报告，根据客户反馈和要求及时做出调整和修改。职位要求：1临床医学、卫生统计、流行病学、统计学等相关专业硕士及以上学历；2熟悉医学研究相关的统计方法，熟练运用常用的统计分析软件（等）；3熟悉临床研究思路、方案设计、样本量计算、随机方案等；4具有很强的责任心及工作热情，能够投入较多的时间和精力，做事细致耐心。
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