Associate Director – Biostatistics

🔥 1 hour ago

🇨🇦 Canada – Remote

💵 $175k - $210k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 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

• Manage clinical trial programs/projects from one or multiple clients with senior Biostatistics, Statistical Operations, or Biometrics leadership • Provide day-to-day technical and operational leadership to project teams • Coach, mentor, develop, review, and advise direct and indirect Biostatisticians and Statistical Programmers • Lead statistical and programming teams and plan and implement project plans with clients and internal project leaders • Ensure sound statistical methodologies across study design, sample size estimation, analysis planning, data handling, modeling, testing, analysis, and reporting • Provide statistical input to protocol design and development and participate in writing protocols and research proposals • Contribute strategically to drug development and commercialization at study and therapeutic-area levels • Review clinical data management deliverables • Write and peer review SAPs, Statistical Reports, and statistical methodology sections of CSRs • Perform hands-on statistical analysis and modeling • Validate statistical tables, listings, and figures and perform overall QC of statistical deliverables • Review ADaM dataset specifications and perform QC on ADaM datasets • Provide statistical consultation for publication of trial results and participate in writing abstracts, manuscripts, posters, and presentations • Consult with less experienced Biostatisticians • Ensure compliance with regulatory requirements and standards • Interact with regulatory agencies and support Sponsors in new drug applications • Perform resource management, capacity analysis, benchmarking, and performance metrics • Maintain governing documents and contribute to continuous improvement • Participate in interviewing and evaluating professional applicants • Assist with business development, cost estimates, proposals, bid defense meetings, and trade shows • Assist with project budget planning, tracking, reporting, out-of-scope tracking, cost estimates, and change orders

🎯 Requirements

• A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 10 years’ relevant experience OR a Master’s degree in these fields with at least 13 years’ relevant experience • Demonstrated exceptional ability and performance • Expertise in statistical methodologies and regulatory requirements • Experience with clinical trial programs/projects, statistical analysis, modeling, programming, and reporting • Knowledge of clinical data management deliverables, including eCRFs, data validation specifications, Data Review Plans, and Data Management Plans • Experience writing Statistical Analysis Plans, Statistical Reports, Clinical Study Reports, abstracts, manuscripts, posters, and presentations • Knowledge of ADaM dataset specifications and QC activities • Knowledge of relevant regulatory requirements and applicable standards/conventions, including CDISC • Ability to interact with regulatory agencies and support new drug applications • Ability to perform statistical and programming resource management, capacity analysis, benchmarking, and performance metrics • Ability to participate in business development, project budgeting, cost estimation, proposals, bid defense meetings, and change orders

🏖️ Benefits

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