Principal Biostatistician

Ecrscorp; Ontario; Hybrid; CAD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Principal Biostatistician to drive success in clinical research. This role involves managing clinical trial projects, providing statistical oversight, and mentoring junior staff. The ideal candidate will have a Ph.D. or Master's in statistical science, with significant experience in drug development and regulatory compliance. Join a dynamic organization known for its high-quality deliverables and superior customer service, where your contributions will make a meaningful impact on innovative drug therapies. This is an exciting opportunity to be part of a growing team in a forward-thinking environment.

Qualifications

• Ph.D. or Master's in statistics with extensive experience in clinical trials.
• Strong expertise in statistical methodologies and regulatory compliance.

Responsibilities

• Manage clinical trial programs and provide statistical oversight.
• Coach and mentor junior biostatisticians and provide technical guidance.

Skills

Statistical Analysis

Statistical Modeling

Data Management

Clinical Trial Design

Mentoring

Education

Ph.D. in Statistical Science

Master's in Statistical Science

Tools

Statistical Software

CDISC Standards

Job description

Ontario
675 Cochrane Drive
East Tower 4th Floor
Markham, ON L3R0B8, CAN

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 great success.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning 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:

• 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.
• 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.
• Coach, mentor, develop, and provide technical review, advice and expertise to less experienced Biostatisticians as well as Statistical Programmers assigned to the program/projects.
• Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals.
• 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.
• Review and provide input to clinical data management deliverables, including but are 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.
• 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 maintains 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, 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 the clients.
• Review and confirm ADaM dataset specifications. Perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians.
• 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.
• Ensure all study level as well as 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 sponsor in new drug application. This includes participating as a statistical liaison to the regulatory agency on behalf of the sponsor company and ensuring documentation, statistical results, and study datasets meet the regulatory agency’s requirement/expectation (e.g., CDISC).
• Perform statistical and programming resource management, capacity analysis, benchmarking and metrics. Participate in the continuous improvement and maintenance of statistical and programming governing documents.
• Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.

Qualifications and Experience:

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 thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.