Biostatistician

This is a fully remote position, open to applicants in Canada.

📋 Description

• Serve as either support or Lead Biostatistician for various Phase 1 to 4 clinical trials.

• Contribute to the statistical sections of protocols, which includes sample size calculations or validation.

• Engage in the formulation of Risk-based Monitoring Plans.

• Review and provide feedback on Data Management documents and assist with data cleaning processes.

• Create Unblinding Plans, Statistical Analysis Plans, and shells for Tables, Listings, and Figures.

• Evaluate CDISC SDTM trial domains, ADaM datasets, derived datasets, and clinical trial TLFs.

• Examine the statistical sections of Clinical Study Reports to ensure accurate reporting and interpretation.

• Support teams of Statistical Programmers conducting analyses for clinical trials.

• Act as the main Biostatistics liaison for internal departments, Sponsors, and external vendors.

• Oversee timelines for Biostatistics study-team deliverables.

• Review project scopes and budgets; identify out-of-scope work while monitoring forecasts, revenue recognition, and project HPIs.

• Serve as the Unblinded Support Biostatistician by reviewing randomization plans and lists.

• Perform statistical analyses for Investigator Initiated Studies and internal R&D projects.

• Contribute to internal initiatives aimed at enhancing Biostatistics efficiency and quality.

• Stay updated on Industry and CDISC standards, ICH guidelines, and Regulatory Authority requirements.

• May also engage in statistical programming of ADaMs and TFLs, act as an Unblinded Biostatistician, support IDMCs and interim analyses, attend meetings outside regular business hours, and act as a Peer Biostatistician.

⛳️ Requirements

• A Master’s degree or PhD in Statistics, Biostatistics, or a related discipline with relevant applied biostatistics training in clinical trials is required.

• Minimum of 1 year of clinical trials experience in the Biotechnology, Pharmaceutical, and/or Contract Research Organization (CRO) sectors is required.

• A solid understanding of the drug development process, ICH guidelines (including but not limited to ICH E6(R2), E9, and E9(R1)), as well as relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations and guidelines is preferred.

• Significant exposure to clinical trial data, SAPs, and TLF Shells is preferred.

• Familiarity with CDISC standards and guidelines is an asset.

• Proficiency in SAS for analyzing clinical trial data is preferred.

• Highly organized and detail-oriented, possessing effective project planning and time management skills.

• Ability to thrive in a fast-paced environment with a proven capacity to manage and prioritize multiple competing demands.

• Must be capable of working independently as well as collaboratively within a team.

• Strong verbal and written communication skills in English; proficiency in French is considered an asset.

• Must have legal authorization to work in Canada.

🏝️ Benefits

• Permanent full-time position.

• Flexible working schedule.

• Home-based position.

• Continuous learning and development opportunities.

• Attractive prospects for career advancement.

• Equitable treatment and equal opportunity.

• Accommodations provided during the recruitment and selection process for applicants with disabilities, upon request.