Principal Statistician

Adecco is currently hiring for a Principal Statistician for our Medical Manufacturing client in Ottawa West. This is a permanent opportunity offering full time hours, Monday – Friday (8:00am-5:00pm). The salary for this position will be determined based on education and experience.

To qualify for this role, you must have a minimum of 10 years experience working in a Statistician role, over 3 years experience developing protocol methodology and statistical analysis plans. The individual must be flexible and be able to work in a fast-paced environment with changing priorities.

Our client is a diversified health care innovator with a legacy of pioneering work in medical diagnostics and devices. They are dedicated to advancing innovative with-patient diagnostic technology to improve patient care and system efficiency by fundamentally changing the way health care professionals process patients through their system. 

Position Overview:

Working as part of the Clinical Affairs organization, in this role you will 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

Responsibilities:

  • 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 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 the 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 Education and Experience:

  • Undergraduate university Degree in Engineering, Science or Math with a specialty in Statistics or Biostatistics (4 year program).
  • 10-15 years of related experience
  • 3+ 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
  • To be considered for this Principal Statistician opportunity in Ottawa West, please Apply Now!

     




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    Reference CA_EN_1_021956_1703728

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