Principal Biostatistician

Role Description

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Principal Biostatisticians for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.

• 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 the 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 as well as 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.
• Review and provide input to clinical data management deliverables, including but not limited to:
  • eCRFs
  • eCRF Completion Instructions
  • Data validation specifications
  • Data Review Plan
  • Data Management Plan
• Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports.
• Perform peer review of SAPs and other technical documents written by others.
• Perform hands-on statistical analysis and modeling, and maintain 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.
• Perform overall Quality Control review on statistical deliverables before they are released to the clients.
• Review and confirm ADaM dataset specifications. Perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians.
• Provide statistical consultation to medical and clinical trial personnel for the publication of trial results.
• Participate in the writing of abstracts, manuscripts, posters, and presentations.
• Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions.
• Interact with regulatory agencies and support sponsor in new drug application.
• Perform statistical and programming resource management, capacity analysis, benchmarking and metrics.
• Participate in the 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.

Qualifications

• A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 7 years of relevant experience.
• A Master’s degree in these fields with at least 10 years of relevant experience, with demonstrated exceptional ability and performance.

Benefits

• Robust benefits package to support health, well-being, and growth.
• 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.

Company Description

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs.