岗位职责:

1. Be responsible for participating in or drafting relevant designs for specific project plan statistics, statistical analysis plans, reviewing the results of TFLs (Tables, Figures, and Listings), and writing the statistical results of CSR (Clinical Study Reports), etc., thus laying the foundation for the successful completion of the work.

2. Be responsible for conducting statistical evaluation work on the project initiation research or due diligence investigation projects of Qilu, providing statistical support for the project initiation R & D or license-in.

3. Provide statistical support in the communication with CDE (Center for Drug Evaluation) and the post-verification of NDA (New Drug Application) submissions, laying the foundation for the successful completion of the submissions and approvals.

1.负责参与或起草具体项目方案统计相关设计、统计分析计划、TFLs结果审核、CSR统计结果撰写等环节，为顺利完成工作奠定基础；

2.负责对齐鲁立项调研或尽职调查项目统计评估工作，为项目立项研发或license-in做好统计支持工作；

3.提供在CDE沟通和NDA申报后核查中的统计学支持，为顺利完成申报和获批奠定基础。

任职要求:

PhD in Statistics or Biostatistics，with three years or more of working experience in statistics;

Familiar with the drug research and development process and the process of new drug clinical trials;

Well-versed in the policies, regulations of clinical trials and relevant provisions of GCP (Good Clinical Practice);

Master clinical research strategies and statistical methods, and conduct comprehensive management and risk control over the statistical analysis process;

Possess the ability and working experience in clinical statistical analysis of new drugs;

Have the programming ability for new drug clinical research;

With good communication and coordination skills.

博士学历，统计学/生物统计学或其他相关专业；3年及以上统计工作经验；

了解药物研发流程和新药临床试验流程；

熟悉临床试验的政策法规及GCP相关规定；

掌握临床研究策略与统计方法，对统计分析过程进行全面的管理及风险控制；

新药临床统计分析工作能力和工作经验；

新药临床研究编程能力；

良好的沟通协调能力；