Biostatistician - Canada
Core
Lead or support biostatistician for Phase 1-4 clinical trials, managing statistical design, analysis, and reporting to ensure financial health and regulatory compliance.
Role type
Senior IC biostatistician (clinical trials) (via careerplan.io/jobs/15-003-BB-279-biostatistician-canada)
Builds
Statistical Analysis Plans (SAPs), Clinical Study Reports (CSRs), and statistical deliverables for biotechnology and pharmaceutical clients.
Domain
Biotechnology / Pharmaceutical / Contract Research Organization (CRO)
Required skills
Biostatistics, Clinical trial statistics, SAS programming, CDISC standards (SDTM/ADaM), ICH guidelines, Sample size calculation, Data management review, Budget forecasting, Project timeline management
Preferred skills
Drug development process knowledge, Health Canada/FDA regulations, Unblinding plans, Independent Data Monitoring Committee (IDMC) support, Investigator Initiated Studies (IIS)
Technologies
SAS, CDISC SDTM, ADaM, eCRF, DVS
Responsibilities
Act as Lead Biostatistician for multiple clinical trials; Review and input into statistical sections of protocols and CSRs; Develop SAPs and TLF shells; Manage study team timelines and budgets; Review CDISC datasets and TLFs; Support data cleaning and validation; Conduct statistical analysis for internal R&D projects.
Seniority
Senior, hands-on IC