Address
Form of workHybrid: On-Site 1-2 time per week
Location: 4300 Hacienda Dr. Pleasanton ,CA 94588
Pay Rate: $56-$77/hour, paid weekly
12 month contract initially, extension or permanent placement possible pending performance and business needs
Duties
Location: 4300 Hacienda Dr. Pleasanton ,CA 94588
Pay Rate: $56-$77/hour, paid weekly
12 month contract initially, extension or permanent placement possible pending performance and business needs
Duties
- Provide statistical support for clinical trials and other functions such as research & development, quality, and marketing as needed.
- Interacts and consults with clinical and project teams to ascertain their needs and develop appropriate design and statistical solutions.
- Writes statistical analysis plans and reports for use by internal and external customers.
- Critiques and improves study designs developed across the organization.
- Has primary ownership of at least one major project and actively mentors less experienced colleagues as needed.
- Interacts with development and clinical investigators to design clinical trials with appropriate statistical methods and adequate sample size for statistical justification of clinical utility claims.
- Writes statistical analysis plans as needed to capture design elements and statistical methodology.
- Performs statistical analysis and prepares statistical reports of results.
- Reviews statistical analysis conducted by statistical programmers and other biostatisticians to ensure accuracy and quality.
- Conducts randomization and blinding of samples.
- Troubleshoots and improves current statistical designs, including those developed elsewhere in the organization.
- Maintains expertise in state-of-the-art data manipulation and statistical analysis, and mentors less experienced colleagues.
- Manages day-to-day operational aspects of a project.
- Monitors work to ensure quality.
- Knowledge of 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.
- Ability to prioritize and plan work activities.
- Master's Degree in Statistics or a related field is required.
- Ph.D. in Statistics or a related field is preferred.
- 6 years minimum with Masters degree of relevant experience
- 3 years minimum with PhD degree of relevant experience
- Experience with SAS
