Clinical Trial Statistician

2 days ago

Markham, Ontario, Canada Everest Clinical Research Services Inc. Full time

About the Role

We are seeking a highly skilled Clinical Trial Statistician to join our team at Everest Clinical Research Services Inc. in Markham, Ontario.

Job Summary:

The successful candidate will be responsible for processing SDTM and ADaM datasets, conducting statistical analysis, and creating reports based on authorized dataset specifications. They will also collect and consolidate data and programming information from various sources, prepare reports to achieve audit readiness, and maintain current knowledge of pharmaceutical clinical research industry standards.

Main Responsibilities:

  • Data Processing: Process SDTM and ADaM datasets following authorized dataset specifications, including datasets for Clinical Study Reports (CSRs), clinical trial efficacy and safety data integrations (ISS and ISE), and other data analysis and reporting needs.
  • Statistical Analysis: Conduct basic analysis of trends in clinical trial data through developing SAS programming codes for database logical checks and reports for ongoing data review.
  • Data Reporting: Create reports based on statistical analysis plans and statistical TLGs mock-up shells through developing SAS programming codes.
  • Audit Readiness: Collect and consolidate data and programming information from various sources, prepare reports to achieve audit readiness during and at the end of the clinical trials for internal and external quality and compliance audits.
  • Knowledge Management: Maintain current knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements, as well as clinical trial Sponsor-specific requirements when applicable.
  • Team Collaboration: Provide technical guidance and support to less experienced Statistical Programmers in the study teams, may lead statistical research efforts for assigned projects, and participate in the development and maintenance of clinical trial data and statistical reporting standards.

Requirements:

  • Education: Master's degree in statistics, biostatistics, epidemiology, bioinformatics, mathematics, or computer sciences.
  • Experience: 1-3 years of experience in clinical trial statistical programming and/or data analysis.
  • Skillset: Strong capabilities and/or sustained high level of performance as a Statistical Programmer, Microsoft Word, Excel, PowerPoint, Outlook, Project, experience with statistical software is preferred.
  • Personal Qualities: Action-oriented, composure, creative, customer-focused, functional and technical skills, able to learn on the fly, persevere, excellent planning, organizational, time management, and problem-solving skills, prioritize, and pick up on new technical skills quickly.

Benefits:

Eligible for discretionary bonuses and/or salary increases in accordance with company policy, medical, dental, vision, extended health benefits, pension, fitness subsidy, life insurance, paid vacation, sick days, and floater days.

Estimated Salary: $63,453 - $68,500 CAD per annum.

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