Director, Biometrics

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 Little Falls (Greater New York City Area), New Jersey, USA, and Shanghai (Pudong Zhangjiang New District), China.

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 Director, Biometrics for our Little Falls, 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.

Key Accountabilities:

• Provide leadership and expertise in resolving complex operational and technical problems in support of division/company objectives and projects, or as a resource to others. Maintain expertise in industry norms, trends across biometrics and regulatory requirements.
• Provide supervision to ongoing projects by applying management skills, regulatory standards and requirements, 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 biometrics for the company in external business development, regulatory or industry consortiums.
• Represent biometrics functional service group in external and internal audits, as well as qualification/maintenance audits for vendors contracted by Everest.
• Monitor and assess the progress status of ongoing projects. Ensure high quality standards, on time delivery within budget for all stages of the clinical trials – from the trial design, protocol development, statistical analysis planning and execution, to the writing of statistical sections of the Clinical Study Reports or the generation of publications of trial results.
• Support cross-functional biometrics process development, making multi-disciplinary teams more effective by utilizing the strengths of each biometrics functional team.
• Provide leadership and expertise in day-to-day statistical operations and development of statistical methodologies to solve practical statistical problems.
• Serve as a principal level biostatistician, working effectively with interdisciplinary teams to contribute to drug development at the study and drug compound levels. Provide statistical consultation to trial medical/clinical personnel when required.
• Participate in development of study concepts and study protocols.
• Lead statistical and programming teams on assigned projects. Plan and manage resources, timelines, and quality of statistical and programming deliverables.
• Perform planned, ad hoc, and/or exploratory statistical analyses.
• Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports, publications, abstracts, posters, presentations, etc. Review statistical documents generated by others.
• Perform independent validation of statistical results generated by others and perform third level Quality Control review on statistical and programming deliverables before they are released to the clients.
• Interact with regulatory agencies and support client in New Drug Applications/Biologic License Applications. This includes participating as a statistical liaison to the regulatory agency on behalf of the client and ensuring documentation, statistical results, and study datasets meet the regulatory agency’s requirements and expectations (e.g., CDISC).
• Mentor and supervise direct and indirect subordinates. Perform semi-annual and annual performance reviews and prepare developmental plans for direct subordinates and indirect subordinates, where appropriate, through contributing to the performance evaluation process.
• Plan and manage resourcing plans by working with the Project Management group in forecasting resource needs relative to the roles of the personnel. Proactively and continually update the plan with changes to demand, and identify/solution resourcing gaps or overage.
• Participate in recruiting and staffing for responsible functional area, as well as coaching, mentoring, and developing staff members.
• 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.
• 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.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com

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.

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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)