崗位職責:
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.負責參與或起草具體項目方案統計相關設計、統計分析計劃、TFLs結果審核、CSR統計結果撰寫等環(huán)節(jié),為順利完成工作奠定基礎;
2.負責對齊魯立項調研或盡職調查項目統計評估工作,為項目立項研發(fā)或license-in做好統計支持工作;
3.提供在CDE溝通和NDA申報后核查中的統計學支持,為順利完成申報和獲批奠定基礎。
任職要求:
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.
博士學歷,統計學/生物統計學或其他相關專業(yè);3年及以上統計工作經驗;
了解藥物研發(fā)流程和新藥臨床試驗流程;
熟悉臨床試驗的政策法規(guī)及GCP相關規(guī)定;
掌握臨床研究策略與統計方法,對統計分析過程進行全面的管理及風險控制;
新藥臨床統計分析工作能力和工作經驗;
新藥臨床研究編程能力;
良好的溝通協調能力;