Senior Biostatistician
4300 Hacienda Drive Pleasanton CA USA 94588 Pleasanton, CA 94588 US
Job Description
Target Pay Rate: 54.78-77/hr **salary will be commensurate with experienceÂ
Job Description:
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.
Responsibilities:
•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 analyses and prepares statistical reports of results.
•Reviews statistical analyses 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 analyses, and mentors less experienced colleagues.
•Manages day-to-day operational aspects of a project.
•Monitors work to ensure quality.
Skills:
•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.
Education:
•Master's Degree in Statistics or a related field is required.
•Ph.D. in Statistics or a related field is prefered.
Experience:
•6 years minimum with Masters degree of relevant experience
•3 years minimum with PhD degree of relevant experience
•Experience with SAS
**CO/NY candidates may not be consideredÂ
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