Senior Statistician
On-siteToronto, Ontario, Canada
Job Summary
Lead all biostatistics activities for clinical trials, including developing statistical analysis plans, protocols with sample size calculations, and SAS program requirements. Communicate with project teams, clients, and vendors on statistical questions while performing statistical analysis, reporting results, and reviewing QC of deliverables. Consult on experimental design and methods for assessing drug safety and efficacy, liaise with data management on data transfers, and address audit findings. Participate in bid defense and kick-off meetings, train statisticians and programmers, and deliver presentations at investigators' meetings.
Required Qualifications
- MSc in Statistics or equivalent
- Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
- Ability to apply a range of advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information
- Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
- Expert knowledge and understanding of the SAS programming
- Expert knowledge and understanding of CDISC ADaM standard
- Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
- Ability to work in English
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.