Join Everest Clinical Research as a Principal Statistical Programmer

Everest Clinical Research (“Everest”) is a renowned full-service contract research organization (CRO) delivering comprehensive clinical research services to global pharmaceutical, biotechnology, and medical device industries. Collaborate with leading companies and contribute to the development of advanced drugs, biologics, and medical devices.

Why Everest?

Since its establishment in 2004, Everest has evolved from a statistical and data management center to a full-service CRO. With headquarters in Markham (Greater Toronto Area), Ontario, Canada, and additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China, and Taipei, Taiwan, Everest is recognized for its high-quality deliverables, superior customer service, and adaptable client support.

Our commitment to quality, customer focus, and flexibility fuels our growth and success. We seek dedicated, skilled, and customer-focused individuals to join our team as Principal Statistical Programmers at our Toronto/Markham, Ontario, Canada on-site location, or remotely from anywhere in Canada under our Work from Home policy.

Job Responsibilities

• Lead complex projects and resolve intricate statistical programming issues.
• Utilize project management skills to achieve timely and quality deliverables, securing client trust and ongoing business.
• Represent the company in client meetings and interactions regarding statistical programming projects, cost estimates, proposals, and bid defenses.
• Potentially interact with regulatory agencies under supervision.
• Mentor and provide technical guidance to less experienced Statistical Programmers and Biostatisticians.
• Develop and perform quality control (QC) review of SDTM and ADaM dataset specifications for CSRs, ISS, and ISE.
• Validate SDTM and ADaM datasets and perform QC checks using company Working Instruction (WI) checklists.
• Generate, review, and resolve Pinnacle 21 validation issues.
• Conduct overall quality/consistency reviews of statistical TLGs before internal or client delivery.
• Create and perform QC reviews of SDTM and ADaM define.xml files and table of contents.
• Support or lead programming teams for regulatory submission activities.
• Perform quality assessments on regulatory submission programming documents and datasets.
• Develop and maintain expertise in using utilities and macros for Statistical Programmers, and create new ones as needed.
• Conduct QC/validation of complex data integrity checks to ensure data quality.
• Complete required trainings and adhere to Everest and trial Sponsor’s Policies, SOPs, and WIs.
• Document and archive clinical trial data and programming information according to corporate SOPs and guidelines.

Qualifications

• Master’s or Ph.D. in Statistics, Biostatistics, Epidemiology, Computer Sciences with at least 8 years of clinical trial statistical programming experience, OR
• Bachelor’s degree in the above fields with at least 10 years of experience in clinical trial statistical programming.

For more information about Everest Clinical Research and additional opportunities, visit our .

While we appreciate all applicants, only those selected for an interview will be contacted. Everest is dedicated to upholding principles of dignity, independence, integration, and equal opportunity. We encourage applications from people with disabilities and will provide accommodations upon request during the recruitment and selection process.

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Company Name: Everest Clinical Research

Job Title: Principal Statistical Programmer