Senior Biostatistician

🔥 23 hours ago

🇨🇦 Canada – Remote

💵 $110k - $160k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

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.

📋 Description

• Lead resolution of day-to-day work-related issues and problems • Secure quality and improve efficiency and productivity of statistical and programming operations • Lead assigned projects using project management skills, statistical techniques, and programming techniques • Deliver project deliverables with quality and on-time performance • Provide statistical expertise for clinical trial and research project design, analysis, and reporting • Contribute to study protocols, sample size calculations, randomization specifications, and 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 provide input on SDTM specifications • Perform QC validation of analysis datasets and tables, listings, and graphs (TLGs) • Lead statistical dry runs and final runs; manage project resources and resolve data issues with data management • Review Analysis Data Reviewer’s Guides and incorporate reviewer comments • Perform statistical analyses and validation according to SAPs • Plan or contribute to trial results reporting and dissemination meetings • Contribute to and review Clinical Study Reports for accuracy, completeness, and appropriate statistical interpretation • Write statistical reports or statistical sections of CSRs • Perform statistical analyses for publications, abstracts, manuscripts, presentations, and posters • Provide statistical input to CRF design, databases, data collection, data cleaning, and data validation • 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 • Complete required and project-specific training • Comply with company and trial sponsor policies, SOPs, and work instructions • Archive study files according to sponsor requirements • Plan and carry out professional development activities

🎯 Requirements

• Ph.D. degree in statistical science, mathematical analysis or related fields plus 2 years highly relevant experience, or a Master’s degree plus 4 years highly relevant experience • Demonstrated ability and sustained performance • Statistical expertise in the design, analysis and reporting of clinical trials and research projects • Experience with sample size calculation and randomization specifications/codes • Ability to write Statistical Analysis Plans (SAPs) • Experience creating and maintaining Statistical and Programming Quality Control (QC) and QA Plans • Experience developing and/or reviewing ADaM dataset specifications • Experience reviewing SDTM dataset specifications • Experience performing QC validation of analysis datasets and TLGs • Experience with statistical analysis, validation, and reporting for Clinical Study Reports (CSRs) • Experience performing statistical analyses for publications, including abstracts, manuscripts, presentations and posters • Ability to provide statistical input to CRF, database/variable structure, data collection, data cleaning, and data validation specifications • Ability to comply with applicable company and sponsor policies, SOPs, and work instructions • Ability to properly archive study files • Ability to plan and carry out professional development activities

🏖️ Benefits

• Medical coverage • Dental coverage • Vision coverage • Life & AD&D insurance • Short-term disability • Long-term disability • Tuition reimbursement • Fitness reimbursement • Employee assistance program (EAP) • Pension plan • Generous paid time off • Sick leave • Opportunity to earn a performance based bonus • Home-based office remote work option in accordance with the Work from Home policy