崗位職責:

This position provides statistical support to development and clinical research projects; interacts with research personnel to ascertain needs and develops appropriate design and statistical solutions. Develops/Coordinates statistical analysis plans (SAPs) and statistical reports for use by internal and external customers. Monitors work to ensure quality, and continuously promote Quality First Time and ensures compliance with the company SOPs, Policies, Directives, Divisional standards, Declaration of Helsinki, Industry standards, relevant GxPs, both CNMPA and/or international requirements and/or best practices.

1. Interact with product developers and clinical investigators to design clinical trials with appropriate statistical methods and adequate sample size for statistical justification of clinical utility claims.

2. Write data analysis plans as needed to capture design elements and statistical methodology.

3. Perform/Support data analysis and prepares statistical reports of results.

4. Perform Quality Control (QC) for statistical analyses to ensure analysis quality.

5. Conduct randomization and blinding of samples, if apply.

6. Maintain expertise in state-of-the-art data manipulation and statistical analyses.

7. Manage technical aspects of project(s), as assigned.

8. Monitor work to ensure quality, and continuously promotes Quality First Time.

9. If apply, be a contact window, develop and maintain a good working relationship with BAs and other dept. to support the cross-functional projects

10. Other projects or tasks assigned by line manager

11. Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection

任職要求:

1. At least Master degree in Statistics or a related field, at least 3 years of relevant experience

2. Proficiency in English language skills

3. Good command of SAS or other statistical software

4. Understand pharmaceutical and/or medical device regulation and ICH/GCP

職位福利：五險一金、年底雙薪、績效獎金、餐補、帶薪年假、補充醫療保險、通訊補助、定期體檢