Biostatistician - Canada
Core
Support or Lead Biostatistician for Phase 1-4 clinical trials, managing statistical aspects, protocols, and data analysis.
Role type
Senior IC Biostatistician (Clinical Trials) (via careerplan.io/jobs/15-003-BB-279-biostatistician-canada-at-indero)
Builds
Statistical Analysis Plans (SAPs), Clinical Study Reports (CSRs), and statistical sections of protocols.
Domain
Biotechnology / Pharmaceutical / Contract Research Organization (CRO)
Required skills
Biostatistics, Clinical trial design, SAS, CDISC standards (SDTM/ADaM), ICH guidelines, Data management, Project management
Preferred skills
Drug development process, Health Canada/FDA regulations, TLF shells, Unblinding plans, Independent Data Monitoring Committees (IDMC)
Technologies
SAS, CDISC SDTM, ADaM
Responsibilities
Act as Lead Biostatistician for multiple trials; Review and input into statistical sections of protocols and CSRs; Develop SAPs and TLF shells; Manage timelines and budgets for study teams; Conduct statistical analysis for Investigator Initiated Studies (IISs); Review Randomization Plans and Unblinding Plans.
Seniority
Senior, hands-on IC