Everest Clinical Research is a full-service contract research organization serving pharmaceutical, biotechnology, and medical device industries worldwide. Founded in 2004, Everest operates out of Markham, Ontario, with additional sites in the United States, China, and Taiwan. Senior Biostatisticians will work onsite in Markham or remotely from any location in Canada in accordance with our Work from Home policy. Key Accountabilities Leadership and Project Management: Resolve day‑to‑day work issues, secure quality, and improve efficiency and productivity of statistical and programming operations. Lead assigned projects applying project‑management skills, statistical and programming techniques to achieve quality, on‑time delivery, and client trust. Statistical Planning and Methodologies: Provide expertise for design, analysis, and reporting of clinical trials; contribute to protocols, calculate sample size, develop randomization specifications, and generate randomization codes; write Statistical Analysis Plans (SAPs) and address peer statistician review comments; create and maintain QC/QA plans; provide input to unblinded data‑management plans and assist in research and development of statistical methodologies. Statistical Programming: Develop and review ADaM dataset specifications; review and provide input to SDTM specifications; perform QC validation of analysis datasets and TLGs; conduct third‑level review of dry runs and final runs; lead statistical dry runs and final runs; review the Analysis Data Reviewer’s Guide and incorporate Data Standards Reviewer comments. Statistical Analysis, Reporting, and Publication Support: Perform analysis per SAP, address peer/QC review comments; validate core results; plan and conduct trial results reporting meetings; under supervision contribute to deviations in the Clinical Study Report (CSR) and review CSR for accuracy; write statistical sections of CSR; perform analyses for publications, abstracts, manuscripts, presentations, and posters. Supporting Clinical Data Collection and Cleaning: Provide statistical input to CRF design and database/variable structure; provide input to non‑CRF data collection; review Data Management Plan sections; provide input to Data Validation Specification; specify programed database quality acceptance checks; assess and report data quality issues; assist team in preparing for database lock; complete required training; archive study files; plan professional development activities. Qualifications and Experience A Ph.D. in statistical science, mathematical analysis, or related fields plus 2 years of highly relevant experience, or a Master’s degree plus 4 years of highly relevant experience, demonstrating sustained performance. Benefits & Compensation We offer a robust benefits package including medical, dental, and vision coverage, life & AD&D insurance, short‑ and long‑term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and a performance‑based bonus. Estimated salary range: $110,000 – $160,000. 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
Senior Biostatistician
EVEREST CLINICAL RESEARCH
markham, markham
Published 27 days ago
Report job