Senior Biostatistician

Agilus Work Solutions

Ottawa

On-site

CAD 95,000 - 110,000

Full time

2 days ago
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Benefits offered by this job

6 month contract

Job summary

Agilus Work Solutions in Ottawa, Ontario is seeking a Senior Statistician to lead the design, analysis, and interpretation of clinical and R&D studies supporting medical devices. You will mentor colleagues, influence strategic decisions, and ensure statistical excellence across product development and regulatory initiatives.

The role requires 6+ years in biostatistics, advanced R skills, and knowledge of SAS/JMP/Minitab/NCSS PASS.

Qualifications

  • Minimum 6 years of biostatistics experience in medical devices or pharmaceutical industries.
  • Advanced proficiency in R is required.
  • Strong knowledge of SAS, JMP, Minitab, NCSS PASS, and Analyze-IT.
  • Ability to design clinical study designs and statistics for regulatory submissions (medical devices).
  • Familiarity with ICH-GCP, FDA 510(k) guidelines is desirable.
  • Master's degree in Statistics or related fields; WES if educated outside Canada.
  • Eligible to work full-time in Canada and willing to undergo a background check.

Responsibilities

  • Designs, plans, and executes biostatistical components of R&D plans for medical devices.
  • Ensures accuracy of report text and aligns statistical tables with listings.
  • Leads as the statistical SME across R&D programs.
  • Presents results to cross-functional teams and explains statistical concepts.
  • Identifies and corrects misinterpretations and presentation inconsistencies.
  • Leads process improvements in statistics and data analytics.
  • Mentors junior statisticians and develops training tools.
  • Supports a healthy workplace culture.

Skills

R programming
SAS
JMP
Minitab
NCSS PASS
Analyze-IT
Biostatistics

Education

Master's in Statistics/Biostatistics
WES certification (if degree not from Canada)

Job description

Drive the Statistics Behind Innovative Medical Devices: Lead Clinical Data Strategies That Shape Patient Care

Aglus is recruiting for a Senior Statistician in the Life Sciences Industry in Ottawa, Ontario. Are you a seasoned biostatistician looking to make a meaningful impact in healthcare innovation?

We are seeking a Senior Statistician to lead the design, analysis, and interpretation of clinical and R&D studies supporting cutting-edge point-of-care medical devices. In this highly visible role, you'll collaborate with multidisciplinary teams, influence strategic decisions, mentor colleagues, and ensure statistical excellence across product development and regulatory initiatives.

Responsibilities
  • Designs, plans, and executes biostatistical components of plans for R&D projects that establish the conditions essential for determining safety, efficacy, and marketability of medical devices.
  • Ensures accuracy of report text and consistency between summary tables in the body of reports and the corresponding statistical tables and listings.
  • Acts independently as a lead statistical subject matter expert for various R&D programs.
  • Presents results of statistical analyses to cross-functional stakeholders, and communicates basic statistical concepts to other cross-functional team members.
  • Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference to clients report guidelines.
  • Leads process improvement initiatives as related to statistics and data analytics.
  • Manages junior staff where applicable, and develops mentorship and training tools for early-career statisticians.
  • Safeguard the environment and facilitate a healthy workplace culture.
Must have
  • Minimum 6 years related work experience as a biostatistician in the medical device or pharmaceutical industry.
  • Advanced-level programming proficiency in R is mandatory.
  • Advanced knowledge of SAS, JMP; Minitab, NCSS PASS, Analyze-IT (or equivalent statistical software).
  • The ability to develop appropriate clinical study design and statistical methodology to support regulatory submissions for medical devices.
  • Knowledge of International Harmonized Committee Good Clinical Practices, IHC/GCP, FDA 510K Clearance Guidelines and Best Practices is desirable.
  • Master’s degree in Mathematics (specialty in Statistics or Biostatistics). Other relevant disciplines include Data Science, Engineering, or Epidemiology. (WES certification if education obtained outside of Canada)
  • Must be legally eligible to work full-time in Canada.
  • Must be willing to complete a criminal background check as part of the formal onboarding process.
Soft skills
  • Excellent communications skills, both oral and written.
  • Ability to work cross-functionally with multiple teams.
  • Proven ability to demonstrate strong decision-making and problem-solving skills.
Benefits & Compensation
  • $95000.00 - $110000.00 annually.
  • Join a team developing innovative healthcare technologies that impact patient outcomes.
  • Lead high-visibility statistical initiatives across multiple R&D programs.
  • Mentor and support the growth of emerging statistical professionals.
  • 6 month contract.
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