Principal Biostatistician

Résumé du poste

The Principal Biostatistician will provide technical and operational leadership for clinical trial programs, ensuring sound statistical methodologies in study design and reporting. They will also mentor junior staff, contribute to protocol development, and ensure all activities comply with regulatory requirements.

Détails du poste

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. We serve some of the best-known 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 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s Corporate headquarters are located in Ontario, Canada and US headquarters in New Jersey, USA, with additional physical offices in Asia and Europe. Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest. 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 Biostatistician for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy. 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 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 (through innovative ideas or applications) to drug development and commercialization at the study and drug compound/therapeutic areas levels. Review and provide input to clinical data management deliverables, including but are not limited to the following: eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and 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 maintains 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 that core results for each responsible trial are complete and accurate. 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, and 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. This includes participating as a statistical liaison to the regulatory agency on behalf of the sponsor company and ensuring documentation, statistical results, and study datasets meet the regulatory agency’s requirement/expectation (e.g., CDISC). 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 and Experience: A 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 the above fields with at least 10 years of relevant experience, with demonstrated exceptional ability and performance. Everest is inviting candidates to apply for this existing vacancy. Benefits & Compensation: We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus. Estimated Salary Range: $150,000 - $200,000. To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com [http://www.ecrscorp.com]. We thank all interested applicants, however, only those selected for an interview will be contacted. Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process. #LI-REMOTE #LI-TK1 #INDHP

Ce que vous ferez

The Principal Biostatistician will provide technical and operational leadership for clinical trial programs, ensuring sound statistical methodologies in study design and reporting. They will also mentor junior staff, contribute to protocol development, and ensure all activities comply with regulatory requirements.

Exigences

Candidates must hold a Ph.D. in statistics or a related field with at least 7 years of experience, or a Master's degree with at least 10 years of relevant experience. Exceptional ability in statistical analysis and regulatory documentation is required.

Avantages

• Medical coverage • Dental coverage • Vision coverage • Life insurance • AD&D insurance • Short-term disability • Long-term disability • Tuition reimbursement • Fitness reimbursement • Employee assistance program • Pension plan • Paid time off • Sick leave • Performance based bonus

Compétences indiquées

• Regulatory Compliance · Souhaitée
• Data Validation · Souhaitée
• Quality Control · Souhaitée
• data management · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Clinical trial management
• Statistical methodology
• Sample size estimation
• Statistical analysis planning
• Statistical modeling
• Data management
• Protocol design
• CDISC
• ADaM
• Regulatory compliance
• Mentoring
• Quality control
• Clinical study reports
• Statistical programming
• Data validation
• Regulatory submission
• Statistical Reporting
• Statistical Analysis
• Time Off Management
• Medical Devices
• Planning
• Research
• Peer Review
• Benchmarking
• Biotechnology
• Biopharmaceuticals
• Customer Service
• Clinical Data Management
• Clinical Research
• Clinical Trials
• Clinical Study Design
• Clinical Study Reports
• Commercialization
• Communications Protocols
• Continuous Improvement Process
• Data Validation
• Data Management
• Drug Development
• Case Report Forms
• Employee Assistance Programs
• Leadership
• Innovation
• Mathematical Analysis
• Operations Management
• Organizational Development
• Pharmaceuticals
• Presentations
• Regulatory Requirements
• Resource Management
• Statistical Modeling

Domaines d’emploi

• Science & Research
• Healthcare
• Data & Analytics
• Management & Leadership
• Principal Biostatistician
• Biostatistician
• Mathematicians, Actuaries and Statisticians
• Biostatisticians
• Statisticians