$80K — $100K *
We currently have a great opportunity available for Senior Principal Biostatistician. The Senior Principal Biostatistician is responsible for the design, analysis and reporting of performance studies for Sysmex in vitro diagnostic (IVD) products. The individual will provide input into protocols, develop and review statistical analysis plans and author/co-author reports with statistical content used to support the performance of Sysmex new and/or modified products. This role will prepare responses to address questions received from regulatory agencies regarding statistical aspects of investigative study designs and analyses. The Senior Principal Biostatistician will have the opportunity to manage staff within the Statistics group. This position reports to the Director of Regulatory Affairs.
Essential Duties and Responsibilities:
1. Independently manage all aspects of a project and statistical analysis for Sysmex studies, implement standardized approaches as appropriate and ensure consistency in statistical methodology, programming standards and data specifications.
2. Perform sample size/power calculations and complex statistical analyses.
3. Prepare derived datasets for analyses using SAS.
4. Program analysis, outputs and validate statistical analyses using SAS in accordance with the SAP.
5. Provide statistical input and review of the CSR for complex studies.
6. Provide mentoring and training to less experienced staff.
7. Manage CROs for statistical overflow needs;
8. Collaborate with various departments including data management, clinical and regulatory affairs to ensure successful implementation of the project plan.
9. Ensure the quality-controlled production of all tables, listings and graphs, the accuracy of numerical and quantitative statements and interpretation of statistical results for reports and regulatory submissions in accordance with the methodology detailed in the SAP and the timeliness specified in the project plan.
10. Perform other duties as defined by manager.
Travel Percentage: 15%
Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.
Valid through: 11/11/2021