
501 - 1000 employees
Founded 2004
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.
🕒 September 3
Where this job comes from
Posted on Everest Clinical Research's careers page, not through a job board
First seen by Remote Rocketship September 3
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501 - 1000 employees
Founded 2004
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.
• Lead efforts to resolve day-to-day work-related issues and improve quality, efficiency, and productivity of statistical and programming operations • Lead assigned projects using project management skills, statistical techniques, and programming techniques • Provide statistical expertise for the design, analysis, and reporting of clinical trials and research projects • Write statistical protocol sections, perform sample size calculations, develop randomization specifications, and generate randomization codes • Write Statistical Analysis Plans and address peer statistician review comments • Create and maintain statistical and programming QC and QA plans • Develop and review ADaM dataset specifications and review SDTM specifications • Perform QC validation of analysis datasets and tables, listings, and figures • Lead statistical dry runs and final runs, manage resources, address questions, and resolve data issues • Review Analysis Data Reviewer’s Guides and incorporate data standards review comments • Perform statistical analyses and validation, address QC findings, and support trial results reporting • Contribute to Clinical Study Reports and write statistical reports or statistical sections • Perform statistical analyses for abstracts, manuscripts, presentations, and posters • Provide statistical input to CRF design, database and variable structures, data collection, data cleaning, and data validation specifications • Specify or program database quality acceptance checks and follow data quality issues through resolution • Assist data management and trial management teams in preparing for database lock
• Ph.D. degree 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 • Demonstrated ability and sustained performance • Complete job-required and project-specific training • Comply with applicable Everest and trial sponsor’s policies, SOPs, and work instructions • Properly archive study files in accordance with trial sponsor’s requirements • Plan and carry out professional development activities
• Equal opportunity and disability accommodations upon request during recruitment and selection • Professional development activities
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