Job Title

Ontario, 675 Cochrane Drive, East Tower 4th Floor, Markham, ON L3R0B8, CAN 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. Everests headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan. 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, customerfocus is our tradition, flexibility is our strengththats usthats Everest. To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customerfocused individuals to join our winning team as Senior Statistical Programmers for our Toronto/Markham, Ontario, Canada onsite location, or remotely from a homebased office anywhere in Canada in accordance with our Work from Home policy. Key Accountabilities: Lead efforts in resolving daytoday workrelated issues and problems, ensuring quality of deliverables, as well as improving the efficiency and productivity of statistical programming work. Lead assigned projects by applying project management skills and statistical programming techniques; achieve ontime delivery of deliverables with quality, as well as earn clients trust and repeat business. Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following companys or clients Standard Operating Procedures (SOPs) and project specific requirements. Perform quality control (QC) review of these documents prepared by others. Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and ISE. Perform CDISC standard compliant checks on SDTM and ADaM datasets. Generate, review, and resolve Pinnacle 21 validation issues. Perform additional QC checks on these deliverables using company Working Instruction (WI) QC checklists. Perform overall quality/consistency review of statistical TLGs before delivering them to the internal team or the client. Create SDTM and ADaM define.xml files. Perform QC review of these files prepared by others. Participate and/or lead programming teams in support of product regulatory submission related activities. Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers. Develop new macros and utilities. Program and perform QC/validation of complex data integrity checks to ensure data quality and ongoing scientific data surveillance. Complete jobrequired and projectspecific training. Comply with applicable Everest and trial Sponsors Policies, SOPs, and WIs. Document data and programming information in accordance with corporate SOPs and guidelines. Archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with corporate archival SOPs and guidelines. Qualifications: A Masters or Ph.D. degree in Statistics, Biostatistics, Epidemiology, and Computer Sciences, with at least four years experience in clinical trial statistical programming OR A Bachelors degree in the above fields with at least six years experience in clinical trial statistical programming. Everest is inviting candidates to apply for this existing vacancy. Benefits & Compensation: Medical, dental, and vision coverage Life & AD&D insurance Short and longterm disability Tuition reimbursement Fitness reimbursementEmployee Assistance Program (EAP) Pension plan Generous paid time off and sick leave Performance based bonus opportunity Estimated Salary Range: $90,000 - $140,000. To find out more about Everest Clinical Research and to review other opportunities, please visit our website at 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. #J-18808-Ljbffr