Statistical Programmer I

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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 companies. We serve some of the best‑known companies and work with many of the most advanced drugs, biologics, diagnostics, and medical devices in development today.

Founded in 2004, Everest has grown from a small biometrics consultancy into a leading full‑service CRO with more than 700 employees and over 100 active clients worldwide. Our continued success is driven by high‑quality deliverables, exceptional client service, and a culture of flexibility and innovation. Everest’s headquarters is located in Markham (Greater Toronto Area), Ontario, Canada, with additional offices in the United States, Bulgaria, Poland, Romania, Croatia, China, and Taiwan, and remote employees across the globe.

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 a Statistical Programmer I , either at our Markham, Ontario on‑site location or remotely from a home‑based office anywhere in Canada in accordance with our Work from Home policy.

Responsibilities – Statistical Programming

• Under supervision, develop and review SDTM and ADaM dataset specifications, annotated Case Report Forms (CRF) and other related documents (e.g., define.xml, reviewer’s guide) based on the Statistical Analysis Plan (SAP), Everest company Standard Operating Procedures (SOPs) and Working Instructions (WIs), industry data standards, regulatory requirements, and trial Sponsor‑specific requirements.
• Program and validate SDTM and ADaM datasets following approved dataset specifications; perform CDISC conformance checks on generated SDTM and ADaM datasets and address conformance findings.
• Develop SAS programs to generate and validate statistical output reports of trial data based on the SAP and TLGs mock‑up shells.
• Provide statistical programming support to Clinical Study Reports, clinical trial efficacy and safety data integrations (Integrated Summary of Safety and Integrated Summary of Efficacy), as well as other data analysis and reporting needs such as regulatory required safety reports (e.g., Development Safety Update Report, 120 Day Safety Update, etc.), ad‑hoc requests, and exploratory data analyses.
• Document data and programming information in accordance with Everest company SOPs and WIs; and achieve audit readiness during and at the end of the clinical trials for internal and external quality and compliance audits.
• Achieve a high rating for each of the defined Everest company and trial Sponsor‑specific statistical programming key performance indicators.
• Maintain current knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements, as well as the knowledge of clinical trial Sponsor‑specific requirements when applicable.
• Comply to Everest company‑specific and clinical trial Sponsor‑specific training requirements.
• Develop and provide expertise in other programming and system administration areas when required.

Responsibilities – Clinical Data Acquisition and Cleaning Support

Requirements

A Master’s or Ph.D. Degree in statistics, biostatistics, epidemiology, public health, bioinformatics, mathematics, or computer sciences, with SAS certified Base / Advanced. Clinical trials programmers are highly preferred; exposure / experience in clinical trial statistical programming and / or data analysis is desirable.

Salary

Estimated Salary Range : $48,000 - $55,000.

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

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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