JOB DESCRIPTION:

The Opportunity

This position works out of our Ottawa location in the Point of Care. We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including Chemistry, Electrolytes, Hematology, Blood Gases, Coagulation, Endocrinology, Cardiac Markers, Neurology, and Informatics. Working as part of the Clinical Affairs organization you will have the chance to assist on the design, analysis, interpretation and documentation of statistical results an provide statistical consultation to technical staff, management, and regulatory agencies. You will also have responsibility for the development of statistical procedures to ensure consistency and use of most adequate statistical techniques division wide and develop statistical material and provide training to statisticians and non-statisticians.

What You'll Do

Responsible for statistical methods sections and statistical analyses in clinical 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.
Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inferences to Abbott guidelines .

Provides meaningful input to the development of a report strategy.
Works collaboratively with peers to develop quality protocols, CRF, schema, and reports per agreed timelines.
Provides accurate and timely answers to routine questions from clients, scientific insight when answering nonstandard questions, and independently pursues analyses suggested by the data.

Can clearly communicate basic statistical concepts to other scientists and nonscientists, acts as SME for group.
Effectively mentors non-statistical peers with regard to basic statistical methodology
May be responsible for providing or reviewing statistical input for verification and validation studies.
Can direct, motivate and train 1-2 less-experienced statisticians by appropriately delegating assignments and reviewing work so projects are delivered on time with suitable quality.

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)

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

The annual base salary for this position ranges from $99,750.00 to $146,300.00 CAD. The salary range provided applies to Canada only and does not apply to any other locations outside of Canada.

The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Clinical Affairs / Statistics

DIVISION:
APOC Point of Care

LOCATION:
Canada > Ottawa : 185 Corkstown Road

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Not specified

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)