Director, Statistical Programming

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, Statistical Programming 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/expertise in resolving complex problems in support of division/company objectives, or assigned projects, or as a consultant to others.
• Represent the company and the statistical programming department in customer development and liaison.
• Provide leadership/expertise in day to day statistical programming.
• Participate in new business development and bidding processes.
• Serve on the management team at the corporate level ensuring divisional needs and concerns are represented.
• Provide high expertise in statistical programming methods and techniques in support of ongoing projects and with clients.
• Interact with regulatory agencies and support sponsor company in new drug application.
• Oversee and participate in the development of a Project Plan, develop and monitor timelines for statistical programming activities for assigned projects.
• Oversee programming support activities of others. When necessary, validate the accuracy, consistency and integrity of the statistical output displays generated by the Study Programmer.
• Direct staff teams on performing statistical programming or resolving difficult problems.
• Monitor and assess the progress status of ongoing projects.
• Serve as primary contact between divisional areas and the client for responsible areas. Manage sponsors and vendor relationship. Participate in regular and ad hoc management meetings with clients.
• Develop statistical programming performance requirements and measurements according to the corporate standards. Perform ongoing assessment/measurement of project team performance against set standards.
• Perform semi-annual and annual performance review and development plans for direct subordinates and, where appropriate, indirect subordinates.
• Participate in the recruiting and staffing for the responsible functions, and coaching, mentoring, and developing staff members.
• Provided technical training to new programmers and biostatisticians.

Qualifications and Experience:

• M.Sc., M.A. or higher degree in Computer Science, Biostatistics, Mathematics or related fields.
• Ten years' related experience.
• An in-depth knowledge of clinical trial data management, statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies. In-depth knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented. Knowledge of clinical trial regulatory and ICH requirements.
• Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to FDA. Must possess in-depth level understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to the relevant functions and operations. Must have sound technical judgment and experience in process design and implementation in relevant areas. Strong leadership and drive to achieve goals will be required in order to build the standardization portfolio.

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)