Clinical Research Associate monitoring Canadian clinical trials for Parexel, a global clinical research organization. Managing site relationships, compliance, data quality, and study delivery.
About the role
- Biostatistician leading statistical activities for Indero, a dermatology-focused contract research organization. Supporting Phase 1–4 trials, SAPs, CDISC analyses, budgets, and clinical study reports.
Responsibilities
- Act as support or Lead Biostatistician on multiple Phase 1 to 4 clinical trials
- Provide input into statistical sections of protocols, including sample size calculation or validation
- Participate in developing Risk-based Monitoring Plans
- Review and provide input into Data Management documents and support data cleaning activities
- Develop Unblinding Plans, Statistical Analysis Plans, and Table, Listing, and Figure shells
- Review CDISC SDTM trial domains, ADaM datasets, derived datasets, and clinical trial TLFs
- Review statistical sections of Clinical Study Reports to ensure accurate reporting and interpretation
- Support teams of Statistical Programmers performing clinical trial analyses
- Act as the primary Biostatistics contact for internal departments, Sponsors, and third-party vendors
- Manage Biostatistics study-team deliverable timelines
- Review scope of work and budgets; identify out-of-scope work and monitor forecasts, revenue recognition, and project HPIs
- Act as Unblinded Support Biostatistician by reviewing randomization plans and lists
- Conduct statistical analyses for Investigator Initiated Studies and internal R&D projects
- Contribute to internal initiatives improving Biostatistics efficiency and quality
- Keep current with Industry and CDISC standards, ICH guidance, and Regulatory Authority requirements
- May contribute to statistical programming of ADaMs and TFLs, act as Unblinded Biostatistician, support IDMCs and interim analyses, attend meetings outside normal business hours, and act as a Peer Biostatistician
Requirements
- Master’s degree or PhD in Statistics, Biostatistics, or a related field with some applied biostatistics trainings relevant to clinical trials required
- At least 1 year of clinical trials experience in the Biotechnology, Pharmaceutical, and/or Contract Research Organization (CRO) industries required
- Good knowledge of drug development process, ICH guideline (including but not limited to, ICH E6(R2), E9, and E9(R1)), and relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations and guidelines preferred
- Significant exposure to clinical trial data, SAPs, and TLF Shells preferred
- Good knowledge of CDISC standards and guideline an asset
- Good working knowledge of SAS for the purpose of analyzing clinical trial data preferred
- Very organized and detail-oriented, with effective project planning and time management skills
- Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands
- Must be able to work independently and as part of a team
- Strong verbal and written communication skills in English; French an asset
- Must be legally able to work in Canada
Benefits
- Permanent full-time position
- Flexible schedule
- Home-based position
- Ongoing learning and development
- Attractive advancement opportunities
- Equitable treatment and equal opportunity
- Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request
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