Associate Director, Biostatistics

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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 headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai, China and Taipei, Taiwan.

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

Associate Director, Biostatistics (Statistical Operations) for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.

• Work with an Executive Biostatistics team to manage clinical trial programs/projects from one or multiple clients and provide day-to-day technical and operational leadership to project teams.
• Coach, mentor, develop, and provide technical review and advice to direct and indirect subordinate Biostatisticians and Statistical Programmers assigned to the programs/projects.
• Conduct semi-annual and annual performance reviews and develop developmental plans for subordinates.
• Lead statistical and programming teams, interact with clients and internal project leaders to plan and deliver statistical and programming project plans and quality deliverables.
• Ensure sound statistical methodologies in study design, sample size estimation, analysis planning, data handling, modeling, testing, analysis, and reporting.
• Provide statistical input in protocol design and development; participate in writing trial protocols and research proposals.
• Serve as a principal level Biostatistician, collaborating with interdisciplinary teams to contribute to drug development and commercialization at study and drug program levels.
• Review and provide input to clinical data management deliverables (eCRFs, data validation specs, Data Review Plan, DMP).
• Write SAPs, Statistical Reports, and methodologies sections of CSRs; perform peer review of SAPs and other technical documents.
• Perform hands-on statistical analysis and maintain expertise in state-of-the-art methodology and regulatory requirements.
• Validate core statistical tables, listings, and figures; perform overall QC on statistical deliverables before release.
• Review and confirm ADaM dataset specifications and perform QC on ADaM datasets.
• Provide statistical consultation for publications and participate in writing abstracts, manuscripts, posters, and presentations.
• Act as a consultant to less experienced Biostatisticians; ensure compliance with regulatory requirements and applicable standards.
• Interact with regulatory agencies and support Sponsor in new drug application, serving as a statistical liaison and ensuring documentation and results meet regulatory expectations (e.g., CDISC).
• Manage statistical and programming resources, capacity analysis, benchmarking, and performance metrics; contribute to ongoing process improvements.
• Participate in organization development and growth, including interview/evaluation activities for applicants.
• Assist in business development activities, including cost estimates, project proposals, bid defenses, and participation in professional events as required.
• Participate in budgeting, tracking, and reporting for statistical and programming projects; track out-of-scope services and draft change orders as needed.

• Ph.D. in statistical science, mathematical analysis, or related field with at least 10 years of relevant experience, or a Master’s degree with at least 13 years of relevant experience.
• Demonstrated exceptional ability and performance.

Estimated Salary Range: $175,000 - $210,000.

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.