Principal Biostatistician

🕒 Yesterday

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $150k - $200k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 Statistical Operations management • Provide day-to-day technical and operational leadership to project teams • Provide statistical oversight for assigned drug development programs/projects • Provide statistical input into protocol design and development • Participate in writing trial protocols and research proposals • Serve as primary biostatistician for interdisciplinary teams and contribute strategically to drug development and commercialization • Review clinical data management deliverables, including eCRFs, completion instructions, validation specifications, data review plans, and data management plans • Write Statistical Analysis Plans, Statistical Reports, and statistical methodology sections of Clinical Study Reports • Perform peer review of SAPs and other technical documents • Perform hands-on statistical analysis and modeling • Validate statistical tables, listings, and figures • Perform quality control review on statistical deliverables • Review and confirm ADaM dataset specifications and perform quality control on ADaM datasets • Consult with medical and clinical trial personnel on publication of trial results • Participate in writing abstracts, manuscripts, posters, and presentations • Ensure statistical and programming activities comply with regulatory requirements and standards • Interact with regulatory agencies and support sponsors in new drug applications • Manage statistical and programming resources, capacity analysis, benchmarking, and metrics • Maintain and improve statistical and programming governing documents • Participate in interviewing and evaluating professional applicants

🎯 Requirements

• Ph.D. degree in statistical science, mathematical analysis or related fields with at least 7 years of relevant experience, or a Master’s degree in these fields with at least 10 years of relevant experience • Demonstrated exceptional ability and performance • Expertise in statistical methodologies for study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting • Experience with clinical trial programs/projects and drug development • Knowledge of regulatory requirements and applicable standards/conventions • Experience with ADaM datasets and specifications • Experience with CDISC and regulatory agency requirements/expectations • Ability to perform statistical analysis, modeling, validation, and quality control • Ability to coach, mentor, develop, and technically review Biostatisticians and Statistical Programmers • Ability to interact with regulatory agencies and support new drug applications • Ability to participate in interviews and evaluation of professional applicants

🏖️ Benefits

• Medical coverage • Dental coverage • Vision coverage • Life & AD&D insurance • Short- and long-term disability • Tuition reimbursement • Fitness reimbursement • Employee assistance program (EAP) • 401(k) retirement / pension plan • Generous paid time off and sick leave • Opportunity to earn a performance based bonus • Work from home policy