1.教育背景:博士学历,生物统计或医学统计相关专业。 2.工作经验:精通临床数据收集、整理、和挖掘分析工作;精通临床试验设计与统计分析流程,10年以上工作经验;具备国际临床试验经验和国际主流监管机构沟通经验。 3.专业技能:精通国内外临床试验相关的生物统计学技术指导原则,熟练运用临床试验常规统计软件;熟悉临床试验国际数据标准、数据管理流程和工具。 4.团队合作:强烈的团队合作意识与责任感。 5.语言能力:具备全英语环境下高效工作的能力。 Requirements: 1.Education: Ph.D. in Biostatistics, Medical Statistics, or a closely related quantitative discipline. 2. Experience: 10+ years of experience with proficiency in clinical data collection, collation, mining and analysis; in-depth mastery of clinical trial design and statistical analysis processes; Experience in international clinical trials and communication with major international regulatory authorities is preferred. 3. Skills: Mastery of domestic and international biostatistics technical guidelines for clinical trials; proficiency in mainstream statistical software; familiarity with international clinical data standards, data management processes, and data management tools. 4. Teamwork: Excellent teamwork and strong sense of responsibility. 5. Language: Fluent in English, with the ability to work efficiently in English environment.
工作职责: 1.负责部门规划及团队能力建设,并组织开展相关业务工作。 2.负责或指导完成临床试验方案统计设计,包括样本量计算、随机和编盲等。 3.负责搭建统计分析、数据管理及其他相关业务平台环境,确保技术实施质量与数据安全等。 4.负责审核或独立撰写统计分析计划,可独立进行研究数据的资料处理和统计分析,负责统计分析与报告审核。 5.负责统计及数据技术相关供应商管理、学术交流与监管沟通。 6.其他领导交办的任务。 Key Responsibilities: 1. Lead departmental planning and capability development, and organize execution of relevant statistical and data-related business functions. 2. Lead or provide guidance on statistical design for clinical trial protocols, including sample size calculation, randomization, and blinding. 3. Build and manage statistical analysis, data management, and related technical platforms, ensuring implementation quality, regulatory compliance, and data security. 4. Manage suppliers engaged in statistics-related services. Review or independently author statistical analysis plans; independently conduct data processing and statistical analysis; and review statistical outputs and corresponding reports. 5. Manage suppliers and vendors for statistical and data technology services, and engage in academic exchange and regulatory interactions related to biostatistics and data standards. 6. Fulfill other tasks assigned by senior leadership.
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