Sysmex

Detail

Salary
negotiable
Location
Remote, OR, USA
Posted by: Martha Damerell
25 May
336 Views
24 Jul EXPIRED

Biostatistician

Remote, OR, USA
Job Description

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
  7. SAP and the timelines specified in the project plan.
  8. Reviews the accuracy of numerical and quantitative statements in the clinical document as well as interpretation of statistical results.
  9. Participates in departmental committees/teams for development and improvement of work process, procedures, and standards.
  10. Other duties as assigned

 

Travel Percentage: 5-10%

Job ID Reference
1591
Desired Skills & Experience

Qualifications

  • Bachelor’s degree in mathematics or statistics required. 8 years of previous experience or an equivalent combination of education or experience combined. 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.
Company
  577 Aptakisic Rd, Lincolnshire, IL, USA
  2245439500
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.
  Workplace
 Remote, OR, USA
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