Job Description - Principal Biostatistician (Quebec City or Montreal or Home Based) (19001026)
Principal Biostatistician (Quebec City or Montreal or Home Based)-(19001026)
The position is responsible for statistical methodology, developing or reviewing of protocols and statistical analysis plans for clinical projects, and acts as the lead statistician on complex global trials and across multiple studies.
Act as the core project team lead to coordinate and manage all statistical project activities.
Provide statistical liaison with the client.
Provide statistical input for protocol and CRF development.
Prepare statistical analysis plans.
Perform validation and statistical quality checks on computer-generated output to verify accuracy.
Review works performed by others and provide recommendations for improvement.
Prepare and review key portions of the integrated clinical/statistical report, including sections related to data handling and statistical methodology, patient accountability, baseline comparability, and efficacy and safety results.
Attend regulatory agency meetings and respond to questions to support the statistical analysis results of clinical trials on behalf of the sponsor.
Undertake statistical consultancy for sponsor companies.
Follow departmental SOPS, OGs and relevant regulatory guidelines (e.g. ICH).
Supervise, coach, and mentor staff
Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching
Set priorities and schedule activities of departmental resources, implement company objectives, and create alternative solutions to address business and operational challenges
· Graduate Degree in Statistics or related discipline
MINIMUM TRAINING & EXPERIENCE REQUIRED:
Ten (10) years' experience in statistical analysis of clinical trials as demonstrated by the ability to lead multiple complex and/or global projects with teams of statisticians
Strong statistical skills as evidenced by participation in publications or presentations in areas relevant to clinical trial design and analysis
Proficiency in SAS programming
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
Ability to travel may be required (approximately 1 %)
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
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