工作职责：

1.1 Participate in the design and review of clinical protocols, including preparation of statistical sections, sample size calculations, randomization, and study design.
参与临床方案的设计和审阅，包括统计学部分的准备、样本量计算、随机化和研究设计。
1.2 Work closely with data management teams in the development of case report forms, database specifications, and database validation checks.
与数据管理团队密切合作，开发制定病例报告表、数据库规范和数据库验证检查。
1.3 Work closely with statistical programming team to provide guidance to the statistical analysis. Do QC for TLFs.
与统计编程团队密切合作，为统计分析提供指导。对TLF进行质量检查。
1.4 Analyze clinical trial data and deliver reports to stakeholders.
分析临床试验数据并向利益相关方提交报告。
1.5 Follow Standard Operating Procedures (SOPs) and assist in creating new SOPs. Assist in creating departmental guidelines, company standards and efficient processes.
遵循标准操作规程（SOP）并协助创建新的SOP，协助制定部门指导方针，公司标准和高效流程。
1.6 Provide oversight to vendor to ensure the quality and speed of the statistical tasks. Actively oversee the project timeline and work closely with vendor to ensure all statistical related milestones are achieved. Monitor and review vendor’s work. Provide technical guidance to vendor in all relevant activities at study level.
监督供应商，确保统计任务的质量和速度。积极监督项目时间表，并与供应商密切合作，确保实现所有统计相关里程碑。 监督和审查供应商的工作，就研究层面的所有相关活动向供应商提供技术指导。
1.7 Conduct exploration and practical application of statistical methodologies to support the design, analysis, and interpretation of clinical studies.
开展统计方法的探索与实践应用，以支持临床研究的设计、分析和结果解释。
1.8 Complete other tasks assigned by the supervisor.
完成主管交办的其他工作。

任职资格：

2.1 PhD in Biostatistics or Statistics with at least 1.5 years of working experiences in clinical trials.
生物统计学或统计学博士学历，至少1.5年临床试验工作经验。
2.2 Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions are preferred.
具有样本量计算、方案设计、SAP和准备临床研究报告（包括综合分析总结）的经验。
2.3 Good SAS or R programming skills for generating and QCing critical Efficacy/Safety tables. Knowledge of R programming a plus.
良好的SAS或者R编程技能，可生成和验证关键有效性/安全性表格。 有R编程知识者优先。
2.4 Good problem-solving skills, strategic thinking skills, and communication skills.
良好的解决问题能力、战略思维能力、沟通能力。
2.5 Experience working with cross-functional teams, a Study Management Team (SMT) or similar teams for different clients.
具有与跨职能团队、研究管理团队（SMT）或不同客户的类似团队合作的经验。
2.6 Team player; willingness to go the extra distance to get results, meet deadlines, etc.
具有团队合作精神，愿意付出额外努力按照项目时间表交付成果等。
2.7 Ability to be flexible when priorities change and deal with ambiguity.
能够在优先事项发生变化时灵活处理问题。