Principal Biostatistician

Everest Clinical Research Services Inc; Markham; Hybrid; CAD 100,000 - 130,000; Full time

Job summary

A leading clinical research organization is looking for a skilled Principal Biostatistician to oversee statistical aspects of clinical trials. This role involves mentoring junior staff, ensuring adherence to regulatory requirements, and collaborating across departments to facilitate drug development. The successful applicant will possess advanced qualifications and extensive experience in biostatistics and statistical methodologies.

Qualifications

• Minimum 7 years experience with a Ph.D. or 10 years with a Master's.
• Exceptional ability and performance in statistical modeling.
• Strong background in regulatory requirements.

Responsibilities

• Manage clinical trial programs and provide statistical oversight.
• Coach and mentor less experienced Biostatisticians.
• Ensure compliance with regulatory standards and quality control.

Skills

Statistical analysis

Leadership

Mentoring

Quality control

Regulatory compliance

Education

Ph.D. in statistical science

Master's degree in statistical science

Job description

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada, with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China, and Taipei, Taiwan.

Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength… that’s us… that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our team as Principal Biostatisticians for our Toronto / Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Key Accountabilities :

1. Work with a leader of the Statistical Operations management team to manage clinical trial programs / projects from one or multiple clients. Provide day-to-day technical and operational leadership to project teams supporting these programs / projects.
2. Provide statistical oversight on projects in the assigned drug development programs / projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting.
3. Coach, mentor, develop, and provide technical review, advice, and expertise to less experienced Biostatisticians as well as Statistical Programmers assigned to the program / projects.
4. Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals.
5. Serve as a primary biostatistician, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound / therapeutic areas levels.
6. Review and provide input to clinical data management deliverables, including but not limited to the following: eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan.
7. 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.
8. Perform hands-on statistical analysis and modeling, and maintain expertise in state-of-the-art statistical methodology and regulatory requirements.
9. Validate core statistical tables, listings, and figures programmed by statistical programmers and/or biostatisticians, ensuring that core results for each responsible trial are complete and accurate. Perform overall Quality Control review on statistical deliverables before they are released to clients.
10. Review and confirm ADaM dataset specifications. Perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians.
11. Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentations.
12. Ensure all study-level as well as drug program-level statistical and programming activities are conducted in compliance with relevant regulatory requirements and standards.
13. Interact with regulatory agencies and support sponsors in new drug application submissions. This includes participating as a statistical liaison to regulatory agencies on behalf of the sponsor and ensuring documentation, statistical results, and study datasets meet regulatory expectations (e.g., CDISC).
14. Perform statistical and programming resource management, capacity analysis, benchmarking, and metrics. Participate in the continuous improvement and maintenance of statistical and programming governing documents.
15. Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.

Qualifications and Experience :

A Ph.D. 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, demonstrating exceptional ability and performance.