Job Title

Join to apply for the Statistical Programmer I role at Everest Clinical Research Everest Clinical Research ('Everest') is a fullservice contract research organization (CRO) providing a broad range of expertisebased clinical research services to worldwide pharmaceutical, biotechnology, and medical device companies. We serve some of the bestknown 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 fullservice CRO with more than 700 employees and over 100 active clients worldwide. Our continued success is driven by highquality deliverables, exceptional client service, and a culture of flexibility and innovation. Everests 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 customerfocused individuals to join our winning team as a Statistical Programmer I, either at our Markham, Ontario onsite location or remotely from a homebased 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, reviewers 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 Sponsorspecific 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 mockup 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.), adhoc 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 Sponsorspecific 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 Sponsorspecific requirements when applicable. Comply to Everest companyspecific and clinical trial Sponsorspecific training requirements. Develop and provide expertise in other programming and system administration areas when required. Responsibilities Clinical Data Acquisition and Cleaning Support Develop and maintain SAS programs to perform database integrity checks and work with Data Managers to address data issues and queries for ongoing data cleaning and review. Support data acquisition of nonCRF data by developing SAS programs to reconcile the CRF and nonCRF data and performing data integrity checks of the nonCRF data. Develop SAS programs to generate data listings, summary tables, and graphs for ongoing data cleaning and scientific data surveillance reviews (safety, missing data, trending and signaling, etc.). Develop SAS programs to generate Patient Profiles to support trial subject case review activities. Requirements A Masters 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 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. #J-18808-Ljbffr