Manager, Biostatistics

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 Manager, Biostatistics 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:

• Work with a Director, Senior Director, and/or Executive Director of Biostatistics 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.
• Lead statistical and programming teams and interact with clients and/or Everest internal project leaders to plan and implement statistical and programming project plans, and deliver quality deliverables.
• Ensure sound statistical methodologies in the study design, sample size estimation, statistical analysis planning, data handling, statistical modeling and testing, analysis and reporting.
• Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals.
• Serve as a principal level 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 Management Plan, and Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the 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.
• Review and confirm ADaM dataset specifications. Perform quality control activities on ADaM datasets programmed by other Statistical Programmers and Biostatisticians.
• 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.
• 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.
• Coach, mentor, develop, provide technical review, advice and expertise to direct subordinate Biostatisticians and Statistical Programmers as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to the programs/projects.
• Perform semi-annual and annual performance review and develop developmental plans for direct subordinates and, where appropriate, indirect subordinates through contributing to the performance evaluation process.
• Act as a consultant to less experienced Biostatisticians.
• 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.
• Perform statistical and programming resource management, capacity analysis, benchmarking and generation of performance metrics. Participate in the continuous improvement and maintenance of statistical and programming governing documents.
• Assist in business development activities, including but not limited to the following: provide cost estimates of statistical and programming services; participate in generation of project proposals and bid defense meetings; and participate in professional trade shows when required.
• Participate and/or assist in statistical and programming project budget planning, tracking and reporting.
• Perform tracking of out of scope services on assigned projects, provide cost estimates and draft change orders to existing services work orders.

Qualifications and Experience:

• A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 5 year’s relevant experience or a Master’s degree in these fields with at least 8 year’s relevant experience, with demonstrated exceptional ability and performance.

• Significant contribution, outstanding and 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)