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.
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 Director, Biostatistics working remotely (or in office) in the United States.
Job Accountabilities: Provide leadership and expertise in resolving complex operational and technical problems in support of division/company objectives and projects.Maintain expertise in industry norms, trends across biostatistics, statistical programming, and regulatory requirements.Provide supervision to ongoing projects by applying management skills, regulatory standards, and quality management to ensure quality and timely deliverables.Build and maintain relationships with assigned clients to ensure biometrics services are well represented and that communication with the client and the functional teams are clear.Represent biostatistics and statistical programming for the company in external business development, regulatory or industry consortiums.Represent biostatistics and statistical programming functional service groups in external and internal audits.Monitor and assess the progress status of ongoing projects, ensuring high quality standards and on-time delivery within budget for all stages of the clinical trials.Provide leadership and expertise in day-to-day statistical operations and development of statistical methodologies.Serve as a principal level biostatistician, working effectively with interdisciplinary teams to contribute to drug development.Participate in development of study concepts and protocols.Lead statistical and programming teams on assigned projects.Perform planned, ad hoc, and/or exploratory statistical analyses.Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports.Perform independent validation of statistical results generated by others and conduct third level Quality Control review on statistical and programming deliverables.Interact with regulatory agencies and support clients in New Drug Applications/Biologic License Applications.Mentor and supervise direct and indirect subordinates, performing performance reviews and preparing developmental plans.Plan and manage resourcing plans by working with the Project Management group.Participate in recruiting and staffing for the functional area.Contribute to the company's management team function and activities.Qualifications and Experience: A Ph.D. degree in statistical science, mathematical analysis, or related fields with at least 12 years of relevant experience or a Master's degree in these fields with at least 15 years of relevant experience and a minimum of 4 years managing people, with demonstrated exceptional ability and performance.
Significant contribution, and/or outstanding/sustained performance may be used in lieu of the requirement on the number of years of relevant experience.
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