Job Title: Biostatistics & Data Management Associate

Location: Remote, home-based position Alberta, Canada based

Compensation: $90,000 - $110,000 - Compensation offered will reflect the skills and experience of the candidate.

Job Type: Full-time, permanent position; standard hours are 40 hours per week

About Us

CovarsaDx is a clinical research organization (CRO) that is dedicated to clinical studies for IVD (in vitro diagnostic) and medical device trials. Our clients experience personalized study strategies, expert consultation, and agile adaptation to changing trial design requirements. We prioritize our clients' regulatory success and clinical research experience, supported by trusted clinical research specialists and resources.

Position Summary

CovarsaDx is seeking a detail-oriented and team-oriented Biostatistics & Data Management Associate to join our US-based remote team. In this role, you will support diagnostic and medical device clinical studies by leading clinical data management and biostatistical activities that help ensure study data are accurate, complete, reliable, and ready for sponsor deliverables, clinical study reports, and regulatory submissions.

This is an excellent opportunity for someone who enjoys applying statistical and data management expertise in a regulated clinical research environment. You will work closely with clinical operations, regulatory affairs, quality assurance, medical writing, and sponsor teams to turn complex clinical data into meaningful, compliant, and submission-ready outputs.

What You’ll Do

· Lead clinical data management and biostatistics activities for assigned diagnostic and medical device clinical studies.

· Develop and maintain study documentation, including Data Management Plans, Statistical Analysis Plans, data review plans, edit check specifications, and study-specific reports.

· Support database design, validation, data cleaning,



reconciliation, query management, database lock, and final dataset preparation.

· Perform and/or oversee statistical analyses, including descriptive statistics, diagnostic performance analyses, agreement analyses, confidence intervals, and other study-specific analyses.

· Prepare statistical outputs, including summary reports, tables, listings, figures, final study datasets, and clinical study report inputs.

· Collaborate with cross-functional teams and sponsors to support study design, endpoint evaluation, data review, reporting, and regulatory objectives.

· Configure, program, validate, and maintain EDC systems, study databases, edit checks, reports, and data exports as needed.

· Support continuous improvement of data management and biostatistics processes, standards, and quality systems.

What We’re Looking For

· Master’s degree in Biostatistics, Statistics, Mathematics, Data Science, Epidemiology, or a related scientific discipline required; doctoral degree preferred.

· 5 years of clinical research experience in data management, biostatistics, or a related discipline.

· Strong understanding of clinical trial design, data management principles, statistical methodologies, and regulatory expectations.

· Familiarity with FDA regulations, Health Canada requirements, ICH GCP, ISO 14155, and ISO 13485 is an asset.

What Will Help You Succeed

· Proficiency with statistical software such as R, SAS, or equivalent tools.

· Experience developing data management,



statistical analysis, data review, edit check, and study reporting documentation.

· Working knowledge of EDC systems, study configuration, edit check programming, validation testing, and database maintenance.

· Experience supporting diagnostic or medical device clinical studies is an asset.

· Strong analytical, problem-solving, technical writing, communication, and project management skills.

· Ability to manage multiple priorities, work independently, and collaborate effectively with sponsors, investigators, regulatory teams, and cross-functional colleagues.

Work Environment

· Remote, home-based position in the US.

· Occasional travel may be required.

· Ability to sit and/or stand while working at a computer for extended periods of time.

· Ability to lift and move up to approximately 4.5 kilograms / 10 pounds.

CovarsaDx is committed to providing an inclusive and accessible recruitment process. If you require accommodation during the application or interview process, please let us know and we will work with you to meet your needs.

We have an immediate opening and if you are ready to bring your data management and EDC expertise to a collaborative clinical research team, we’d love to hear from you. If this position sounds like a good career opportunity, we invite you to submit your resume and cover letter for consideration to [email protected].

We look forward to learning more about your experience and interest in joining CovarsaDx.

Pay: $90,000.00-$110,000.00 per year

Benefits

- Flexible schedule

Application question(s):
- Are you proficient with statistical software such as R, SAS or equivalent tools?

Education:
- Master's Degree (required)

Experience:
- Clinical research in data mgmt, statistics or related field: 5 years (required)

Work Location: Remote

📌 Biostatistician & Data Management Associate (Alberta)
🏢 CovarsaDx Canada
📍 Alberta