Senior Biostatistician
4 weeks ago
Everest Clinical Research Services Inc is seeking a highly skilled Principal Biostatistician to join our team in Toronto, Ontario, Canada. As a key member of our Statistical Operations management team, you will be responsible for managing clinical trial programs/projects from one or multiple clients.
Key Responsibilities:- Provide day-to-day technical and operational leadership to project teams supporting clinical trial programs/projects.
- Ensure sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting.
- Coach, mentor, develop, and provide technical review, advice, and expertise to less experienced Biostatisticians and Statistical Programmers.
- Participate in the writing of trial protocols and research proposals.
- Contribute strategically to drug development and commercialization at the study and drug compound/therapeutic areas levels.
- Review and provide input to clinical data management deliverables, including eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan, and Data Management Plan.
- Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports.
- Perform peer review of SAPs and other technical documents written by others.
- Perform hands-on statistical analysis and modeling, and maintain expertise in state-of-the-art statistical methodology and regulatory requirements.
- Validate core statistical tables, listings, and figures programmed by statistical programmers and/or biostatisticians.
- Perform overall Quality Control review on statistical deliverables before they are released to clients.
- Provide statistical consultation to medical and clinical trial personnel for the publication of trial results.
- Ensure all study-level and drug program-level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions.
- Interact with regulatory agencies and support sponsors in new drug applications.
- A Ph.D. degree in statistical science, mathematical analysis, or related fields with at least 7 years of relevant experience.
- OR A Master's degree in the above fields with at least 10 years of relevant experience, with demonstrated exceptional ability and performance.
We offer a dynamic work environment, opportunities for professional growth and development, and a competitive compensation package. If you are a motivated and experienced biostatistician looking for a new challenge, please submit your application.
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