Senior Biostatistician

🕒 September 4

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $110k - $160k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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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 improve quality, efficiency, and productivity of statistical and programming operations • Lead assigned clinical research projects using project management, statistical, and programming techniques • Deliver high-quality project deliverables on time and build client trust and repeat business • Provide statistical expertise for clinical trial and research project design, analysis, and reporting • Write statistical sections of study protocols and Statistical Analysis Plans (SAPs) • Develop and review ADaM dataset specifications and review SDTM specifications • Perform QC validation of analysis datasets, tables, listings, and graphs (TLGs) • Lead statistical dry runs and final runs, manage resources, resolve programming and data issues, and coordinate with data management • Review Analysis Data Reviewer’s Guides and incorporate standards review comments • Perform statistical analyses and validation, address peer/QC review findings, and support results dissemination meetings • Contribute to and review Clinical Study Reports (CSRs) • Perform statistical analyses for abstracts, manuscripts, presentations, and posters • Support CRF design, database structures, non-CRF data collection, validation specifications, and database lock preparation • Complete required training, comply with policies and SOPs, archive study files, and conduct professional development activities

🎯 Requirements

• 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 • Statistical expertise in clinical trial and research project design, analysis, and reporting • Experience with sample size calculation and randomization specifications/codes • Ability to write Statistical Analysis Plans (SAPs) • Experience with ADaM and SDTM dataset specifications • Experience performing QC validation of analysis datasets and TLGs • Experience with statistical analysis, validation, and reporting for Clinical Study Reports (CSRs) and publications • Ability to provide statistical input to CRF design, database/variable structures, data collection, and data cleaning • Ability to complete required training and comply with Everest and sponsor policies, SOPs, and work instructions • Ability to properly archive study files • Commitment to professional development

🏖️ Benefits

• Medical, dental, and vision coverage • Life and 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 • Professional development activities