Biostatistics Leadership Position in Clinical Research

3 hours ago

Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

About Everest Clinical Research Services Inc.

Everest Clinical Research Services Inc. is a reputable full-service contract research organization (CRO) providing comprehensive clinical research services to pharmaceutical, biotechnology, and medical device industries worldwide. Our team collaborates with top companies to advance innovative drugs, biologics, and medical devices.

We have been an independent CRO since 2004, established as a statistical and data management center of excellence. Building on this foundation, we have successfully developed and grown into a full-service CRO. Our headquarters are located in Markham, Ontario, Canada, with additional sites in New Jersey, USA; Shanghai, China; and Taipei, Taiwan.

Our commitment to quality, customer focus, flexibility, and expertise sets us apart. We strive for excellence in every project, ensuring seamless collaboration and timely delivery.

We seek an exceptional Biostatistics Leadership professional to join our Bridgewater, New Jersey, USA site or work remotely from a home-based office in the USA. This role will provide technical leadership, coaching, and mentorship to support clinical trial programs/projects.

Key Responsibilities:

1. Collaborate with senior directors and executive directors to manage clinical trial programs/projects, overseeing day-to-day operations and providing strategic guidance.

2. Develop and implement statistical and programming plans, working closely with clients and internal project leaders.

3. Lead statistical and programming teams, ensuring sound methodologies and delivering high-quality results.

4. Participate in the writing of trial protocols, research proposals, and regulatory submissions.

5. Serve as a principal-level Biostatistician, contributing strategically to drug development and commercialization.

6. Review and provide input on clinical data management deliverables, including electronic Case Report Forms (eCRFs), data validation specifications, Data Review Plan, and Data Management Plan (DMP).

7. Write Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports (CSRs). Perform peer review of SAPs and other technical documents.

8. Perform hands-on statistical analysis and modeling, maintaining expertise in state-of-the-art statistical methodology and regulatory requirements.

9. Ensure compliance with relevant regulatory requirements and applicable standards/conventions.

10. Interact with regulatory agencies and support sponsors in new drug application, ensuring documentation meets regulatory agency requirements.

11. Perform statistical and programming resource management, capacity analysis, benchmarking, and generation of performance metrics.

Qualifications and Experience:

A Ph.D. degree in statistical science, mathematical analysis, or related fields with at least 10 years' relevant experience, or a Master's degree in these fields with at least 13 years' relevant experience. Demonstrated exceptional ability and performance.

Estimated Salary: $120,000 - $150,000 per year, depending on qualifications and experience.

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