As a member of the R&D group, the ideal candidate will be part of the team working on product development and/or product enhancement projects. They will work closely with the Scientists and Engineers to develop study designs and appropriate statistical methods to analyze data from characterization, verification and validation studies. working within the established design control process to prepare related technical documentation. This position requires a solid knowledge of scientific and statistical principals and theories and the ability to implement these in a creative and effective manner.
Our client is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, that serves people in more than 150 countries and employs approximately 73,000 people.
Intermediate Statistician Job 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.
- 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.
- 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.
- Ability to work both independently and as part of a multi-disciplinary team in a multi-departmental environment.
- 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.
- Innovation, ingenuity and originality are valued.
- Beneficial attributes: enthusiasm, decisiveness and adaptability to changing business requirements, self-starter.
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records