Overview
Join to apply for the Principal Biostatistician (Remote) role at Everest Clinical Research. Everest Clinical Research is a full-service contract research organization (CRO) providing clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. Everest has headquarters in Markham, Ontario, Canada, with additional sites in Bridgewater (NJ, USA), Shanghai, China, and Taipei, Taiwan. The company is known for high-quality deliverables, customer focus, and flexibility in meeting client needs. Everest seeks committed, skilled, and customer-focused individuals to join as Principal Biostatisticians for a Bridgewater, NJ on-site location or remotely from a home-based office anywhere in the USA in accordance with the Work from Home policy.
Estimated salary range: $140,000 - $175,000. Everest is committed to equal opportunity and to providing accommodations on request for candidates participating in any part of the recruitment process.
Key Accountabilities
• Work with a leader of the Statistical Operations management team to manage clinical trial programs/projects from one or multiple clients. Provide day-to-day technical and operational leadership to project teams supporting these programs/projects.
• Provide statistical oversight on projects in assigned drug development programs/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 assigned to the program/projects.
• Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals.
• Serve as a primary biostatistician, working effectively with interdisciplinary teams to contribute strategically to drug development and commercialization at the study and drug/therapeutic levels.
• Review and provide input to clinical data management deliverables, including eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan, and related reports and plans.
• Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports. Peer review 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 and perform overall Quality Control review on statistical deliverables before client release.
• Review and confirm ADaM dataset specifications. Perform quality control on ADaM datasets programmed by others.
• Provide statistical consultation for publication of trial results and contribute to abstracts, manuscripts, posters, and presentations.
• Ensure study-level and program-level statistical and programming activities comply with regulatory requirements and applicable standards.
• Interact with regulatory agencies and support sponsor in new drug applications, including acting as a statistical liaison and ensuring documentation and results meet regulatory expectations (e.g., CDISC).
• Perform resource management, capacity analysis, benchmarking, and metrics; contribute to continuous improvement of statistical and programming governing documents.
• Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.
Qualifications and Experience
A Ph.D. in statistical science, mathematical analysis, or related field with at least 7 years of relevant experience, or a Master’s degree with at least 10 years of relevant experience, with demonstrated exceptional ability and performance.
To learn more about Everest Clinical Research and review other opportunities, please visit www.ecrscorp.com.
We thank all interested applicants; however, only those selected for an interview will be contacted.
EEO and Accommodations
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome applications from people with disabilities and will provide accommodations upon request for candidates participating in any part of the recruitment process.
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Experience: 5 years required