Company : Sysmex
Country: United States
Location : Lincolnshire, Illinois
Post: Tue, 21 Sep 2021 13:16:02 GMT
Expires: Tue, 19 Oct 2021 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
Find a Better Way…
…to use your skills and experience.
This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.
…to improve the lives of others.
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.
We currently have a great opportunity available for Biostatistician. The Biostatistician is responsible for providing statistical support in the execution, analysis and reporting of clinical trials for Sysmex products. The position ensures the statistical integrity of the clinical data analyzed. He/she assists with identifying and supporting new efficiencies and technologies for clinical data collection, analysis and reporting. In addition, this person will also assist with the preparation of responses to regulatory agency questions regarding statistical aspects of clinical trials and other investigative study designs and analyses.
Essential Duties and Responsibilities:
1. Assist with generation of appropriate procedures and policies to conduct statistical analysis of clinical trial data.
2. Assist in the preparation of the statistical methodology section of the synopsis and the statistical procedures section of the protocol, including calculating the required sample size and power and ensures the accurate generation of the randomization as appropriate.
3. Assist with implementing standardized approaches to data analysis as appropriate.
4. Assist with preparing and maintaining the Statistical Analysis Plan (SAP) which includes the description of the planned data analyses, statistical methodology, derivation of analysis variables, and formatting of all tables/listings/figures. Ensure consistency in statistical methodology, programming standards, and data specifications with all studies.
5. Collaborate with various parties including data management, clinical and regulatory affairs to ensure successful implementation of the project plan.
6. Program and produce tables, listings and graphs for the clinical documents (study reports, publications, regulatory submissions, etc.) in accordance with the methodology detailed in the SAP and the timelines specified in the project plan.
7. Reviews the accuracy of numerical and quantitative statements in the clinical document as well as interpretation of statistical results.
8. Participates in departmental committees/teams for development and improvement of work process, procedures, and standards.
9. Additional responsibilities 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.
Bachelor’s degree in mathematics/statistics required with 3-5 years experience. Previous experience in regulatory submissions and/or regulatory interactions a plus. Master’s degree preferred.
IVD experience desired. Experience in the preparation of statistical methodology, analysis, reporting, etc.
Knowledge of Clinical Laboratory Standards Institute (CLSI) guidelines for in vitro diagnostic devices (IVD) including precision (reproducibility/repeatability), linearity, accuracy, specificity, detection capability (LoB, LoD, LoQ) and stability required.
Knowledge and skills of SAS and PC application software such as sample size determination and standard IVD analysis are required.
Ability to explain statistical concepts to non-statisticians.
Working knowledge of regulatory guidance in device product registration is required.
The ability to work to tight deadlines while maintaining high standards.
Ability to adhere to strict guidelines & 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.
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