You will be responsible for:
- 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.
- Write statistical analysis plans as needed to capture design elements and statistical methodology.
- Perform/Support data analysis and prepare statistical reports of results.
- Perform quality control (QC) for statistical analyses to ensure analysis quality.
- Conduct randomization and blinding of samples, if apply.
- Troubleshoot and improve current statistical designs.
- Develop novel statistical innovations as needed.
- Continuously monitor the organizational environment for opportunities to improve research design throughout the company.
- Maintain expertise in state-of-the-art data manipulation and statistical analysis, and actively mentor colleagues.
- Manage day-to-day operational aspects of multiple projects
- If apply, be a contact window, develop and maintain a good working relationship with BAs and other dept. to support the cross-functional projects
- Other projects or tasks assigned by line manager
- 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
- Understand and fulfill the responsibility of line manager's SHE tasks and duties (as defined in SHE handbook)
You should have:
- At least Master degree in Statistics or a related field, PHD preferred
- Proficiency in English language skills
- Good command of SAS or other statistical software
- Understand pharmaceutical and/or medical device regulation and ICH/GCP
- Masters with at least 6 years or PhD with 3 years of relevant experience
- One-two years of project management experience is a plus but not prerequisite
- Experience in CNMPA submissions and in vitro diagnostic tests preferred.
- Effective oral and written communication skills; able to get ideas across face-to-face, in group settings as well as in presentation
罗氏是一家提供均等机会的雇主。Research & Development、 Research & Development > Biometrics