|Job Category||Professional Consulting|
|Application Deadline||September 30, 2020|
|Experience Required||2 years|
|Job Duration||1 year|
Responsibilities:Responsible for the statistical methods and statistical analysis in verification and validation protocols and reports.Ensures accuracy of report text and consistency between summary tables in the body of reports and the corresponding statistical tables and listings.Works with Senior Statisticians to understand industry guidance on study designs and appropriate statistical methods.Works collaboratively with peers to develop quality protocols and reports per agreed timelines.Communicates basic statistical concepts to other scientists and non-scientists and acts as a Subject Matter Expert for the group.Participates on cross-functional teams.Responsible for implementing and maintaining the effectiveness of the Quality System.Understand and comply with applicable EHS policies, procedures, rules and regulations.Other tasks and duties as assigned.
Required Education and Experience:BSc, BEng and/or MSc and have demonstrated academic success in Mathematics (specialty in Statistics or Biostatistics), Engineering or Science.Minimum 3-years direct R&D or equivalent experience, preferably in an industrial R&D or manufacturing setting, with medical devices, sensors, microfluidics and reagents.
Required Skills & Abilities:Problem-solving and critical-thinking skills, as evidenced by the ability to organize experiments, analyze data, interpret results, and draw conclusions.Advanced knowledge of descriptive and inferential statistical techniques.Experience with data manipulation, graphical summary of large data sets and report writing (experience with statistical software platforms such as R, SAS JMP® and Minitab® is desirable).Strong written and oral communication skills (English).Experience writing statistical scripts is an asset.Experience working within a Quality System is an asset.Prior experience in new product development preferred.Awareness of FDA (Food and Drug Administration) regulations for in vitro diagnostic manufacturers would be beneficial.Knowledge of experimental design is required.
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