上海招聘

Key Responsibilities:

1. Interact with clinical team to determine protocol design, endpoints selection, appropriate statistical methods, calculation of sample size and power, and other statistical activities;

2. Participate in clinical study and NDA related activities, include but not limited to CSR writing and review, post-hoc analyses of clinical data, exploratory analyses and data mining.

3. Draft SAP (including TFLs), review CRF and database design, implement SAS to check datasets, verify algorithms and outputs, lead data review meeting, review analysis results (TFLs), draft statistical analysis report.

4. Assist in appropriate QA/QC activities on vendors;

5. Communicate with other functions on clinical data analysis requests and statistical issues, and provide statistical expertise support;

6. Mentor junior staff on statistical design and application, and provide statistical expertise training for other functions.

 

Key Competency Requirements:

1. Master degree or above;

2. Statistics, mathematics, biostatistics or related disciplines;

3. No less than 5 years extensive practical experience in biopharmaceutical or CRO companies;

4. Knowledge of multiple therapeutic areas, diabetes is preferred;

5. Familiar with GCP/ICH/CFDA guidelines;

6. Practical experience in application of CDISC CDASH/SDTM/ADAM data standards;

7. Ability to communicate with vendors regarding statistical issues;

8. Strong communication in Chinese and English, written and verbal;

9. Strong executive capability;

10. Strong teamwork awareness.

华领医药技术（上海）有限公司诚聘