Senior Biostatistician

Alexion Pharmaceuticals; Mississauga; On-site; CAD 110,000 - 160,000; Full time

Job summary

Everest Clinical Research is seeking a Principal Biostatistician for Toronto/Markham, Ontario, Canada, with remote work option across Canada. Lead statistical oversight, design input, and collaboration across interdisciplinary teams on drug development programs.

The role requires a Ph.D. or Master's in statistics with extensive experience, SAS/CDISC expertise, and a track record of guiding statisticians and programmers through SAPs, trials, and regulatory submissions.

Qualifications

• Ph.D. with at least 7 years of relevant experience or Master’s with at least 10 years of relevant experience.
• Demonstrated ability to lead statistical programs and collaborate with interdisciplinary teams.
• Experience writing SAPs and Clinical Study Reports; strong regulatory knowledge.

Responsibilities

• Provide statistical oversight on clinical trial programs and projects.
• Write SAPs and statistical reports; perform quality control of deliverables.
• Mentor biostatisticians and programmers; contribute to protocol design and study design decisions.
• Ensure compliance with regulatory requirements and CDISC standards.

Skills

Statistical leadership

Mentoring

Statistical programming

Education

Ph.D. in statistics or related field

Master's in statistics or related field

Tools

SAS

CDISC standards

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, biote...

CA$110,000.00–CA$160,000.00 yearly

Full-time

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, biote...

CA$110,000.00–CA$160,000.00 yearly

Remote

Full-time

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, biote...

CA$120.00–CA$170.00 daily

Remote

Part-time

Headquartered in San Francisco, our investors include.Simulate raw patient-level data and transform it through.Ensure every figure reconciles back to its source.Execute end-to-end analysis pipeline...

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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 Corporate headquarters are located in Ontario, Canada and US headquarters in New Jersey, USA, with additional physical offices in Asia and Europe.

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.

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 winning team as Principal Biostatistician 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.

Benefits & Compensation

We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

Estimated Salary Range: $150,000 - $200,000.