|Job Category||Professional Consulting|
|Application Deadline||August 31, 2020|
|Experience Required||3 years|
|Job Duration||1 year|
Responsibilities:Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products.Uses sound statistical methodology to conduct studies relating to the life processes of plants, animals, and humans.In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and development group methodology standards.Develops and/or applies statistical theories, methods, and software.Organizes and interprets data into tabular forms amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used.Provides specifications and directions to the development group.May partner in program design and in the collection, management and/or reporting of data.
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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