Principal Biostatistician (Remote)

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve leading companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004, known for high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs.

About the role

We are seeking committed, skilled, and customer-focused Principal Biostatisticians to join our team. This role can be based on-site at our Bridgewater, New Jersey, USA location or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.

Responsibilities

• Manage clinical trial programs/projects from one or multiple clients, providing day-to-day technical and operational leadership to project teams.
• Provide statistical oversight on projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting.
• Coach, mentor, develop, and provide technical review, advice, and expertise to less experienced Biostatisticians and Statistical Programmers.
• Provide statistical input in protocol design and development; participate in writing trial protocols and research proposals.
• Serve as a primary biostatistician, contributing strategically to drug development and commercialization at the study and drug compound/therapeutic areas levels.
• Review and provide input to clinical data management deliverables, including eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan, and Data Management Plan.
• Write Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports; perform peer review of SAPs and other technical documents.
• Perform hands-on statistical analysis and modeling, maintaining expertise in state-of-the-art statistical methodology and regulatory requirements.
• Validate core statistical tables, listings, and figures programmed by statistical programmers and/or biostatisticians, ensuring accuracy and completeness.
• Perform overall Quality Control review on statistical deliverables before client release.
• Review and confirm ADaM dataset specifications; perform quality control activities on ADaM datasets.
• Provide statistical consultation for the publication of trial results; participate in writing abstracts, manuscripts, posters, and presentations.
• Ensure compliance with relevant regulatory requirements and applicable standards/conventions for all statistical and programming activities.
• Interact with regulatory agencies and support sponsors in new drug applications, including acting as a statistical liaison and ensuring documentation meets regulatory expectations (e.g., CDISC).
• Perform statistical and programming resource management, capacity analysis, benchmarking, and metrics.
• Participate in continuous improvement and maintenance of statistical and programming governing documents.
• Contribute to organization development and growth by participating in the interview and evaluation process for 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 in biostatistics.

Benefits

• Medical, dental, and 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

Pay

Estimated salary range: $150,000 - $200,000.