Principal Statistician - Point of Care (Ottawa)
$99,750–$146,300 year
On-siteOttawa, Ontario, Canada
Job Summary
Responsible for statistical methods sections and analyses in clinical protocols and reports, ensuring accuracy of report text and consistency between summary tables and listings. Identifies and corrects flaws in result interpretation and inferences to Abbott guidelines while providing meaningful input to report strategy development. Collaborates with peers to develop quality protocols, CRFs, schema, and reports per agreed timelines, and provides accurate, timely answers to routine and nonstandard client questions. Mentors non-statistical peers on basic statistical methodology and may direct or train less-experienced statisticians by delegating assignments and reviewing work. Develops statistical procedures to ensure consistency and provides training to statisticians and non-statisticians division-wide.
Required Qualifications
- Undergraduate university Degree (4 year program), or equivalent experience (Engineering, Science or Math with a specialty in Statistics or Biostatistics)
- 10-15 years of related experience
- 3 plus years developing protocol methodology and statistical analysis plans
- The ability to develop appropriate clinical study design and statistical methodology to support regulatory submissions for medical devices
- Advanced Knowledge of: MS Office, SAS JMP (or equivalent statistical software)
Desired Qualifications
- Knowledge in the following areas is desirable International Harmonized Committee Good Clinical Practices, IHC/GCP
- Current Good Manufacturing Practice 21 CFR Part 820 FDA 510K Clearance Guidelines and Best Practices
- EU IVD Directive Guidelines and Best Practices
- Contract Research Organization (CRO) oversight
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