Job ID: 2528910301
Who we are
At Roche, 82,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.
- Interacts with development and clinical investigators to designs clinical trials with appropriate statistical methods and adequate sample size for statistical justification of clinical utility claims.
- Writes data analysis plans as needed to capture design elements and statistical methodology.
- Performs data analysis and prepares statistical reports of results.
- Performs Quality Control (QC) for statistical analyses by other biostatisticians to ensure analysis quality.
- Conducts randomization and blinding of samples.
- Develops data entry spreadsheets as needed.
- Evaluates databases and statistical analysis programs and interacts with computer groups to determine hardware/software compatibility.
- Maintains expertise in state-of-the-art data manipulation and statistical analyses.
- Manages technical aspects of project(s), as assigned.
- Monitors work to ensure quality, and continuously promote Quality First Time.
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
- Significant experience in analysis and reporting using statistical software required.
- Experience with SAS preferred.
- Design of Experiments (DOE) experience preferred.
- Experience in FDA submissions and in vitro diagnostic tests preferred.
- Knowledge in FDA guidelines for in vitro diagnostic devices and the required statistical basis for sensitivity, specificity, agreement rates, and reproducibility testing required for validation and FDA clearance and approval.
- Strong ability to collaborate across departments and interact with various levels in the organization.
- High attention to detail with skill in producing organized reports.
- Ability to write statistical code and documentation.
- Ability to work in a team-focused environment is essential, as all statistical analyses under design control require both lead statistical analysis and quality control (QC), each conducted by different individuals who must coordinate activities.
The next step is yours. To apply today, click on the "Apply online" button below.
Roche is an Equal Opportunity EmployerApply online