Biostatistician, Senior Principal
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Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.
...to build a promising future.Responsibilities:
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.
Masterâ€™s degree or higher in Biostatistics required. 5-7 years of experience in required. Previous experience in regulatory submissions and/or regulatory interactions preferred.
Knowledge of statistical documentation requirements for FDA product evaluations.
Knowledge of Clinical Laboratory Standards Institute (CLSI) guidelines for in vitro diagnostic devices (IVD).
Knowledge and skills of SAS and PC application software for IVD analysis including precision (reproducibility/repeatability), linearity, accuracy, specificity, detection capability (LoB, LoD, LoQ) and stability are required.
IVD experience desired. Experience in the preparation of statistical methodology, analysis, reporting, etc.
Working knowledge of regulatory guidance in device product registration is required.
Advanced computer skills. Including advanced coding capability.
Advanced capabilities in SAS and other off the shelf statistical software packages.
Database proficiency and software validations proficiency required.
Good interpersonal skills and ability to manage relationships internally and externally.
Effective communication skills, both written and oral.
Ability to explain statistical concepts to non-statisticians.
Excellent organizational skills.
The ability to work to tight deadlines while maintaining high standards.
Ability to adhere to strict guidelines and codes of practice.
Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.