Provides statistical support to development and clinical research projects; interacts with research personnel to ascertain needs and develops appropriate design and statistical solutions. Writes statistical analysis plans (SAPs) and statistical reports for use by internal and external customers.
- 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 data analysis plans as needed to capture design elements and statistical methodology.
- Perform data analysis and prepare statistical reports of results.
- Perform Quality Control (QC) for statistical analyses by other biostatisticians to ensure analysis quality.
- Conduct randomization and blinding of samples.
- Develop data entry spreadsheets as needed.
- Evaluate databases and statistical analysis programs and interact with computer groups to determine hardware/software compatibility.
- Maintain expertise in state-of-the-art data manipulation and statistical analyses.
- Manage technical aspects of project(s), as assigned.
- Monitor work to ensure quality, and continuously promotes Quality First Time.
- Knowledge of FDA guidelines and the required statistical basis for sensitivity, specificity, agreement rates, 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.
- Master's degree in Statistics or a related field
- PhD degree in Statistics or a related field
- Masters plus 3 years statistical analysis in a healthcare environment or PhD plus significant experience in analysis and reporting using statistical software
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