Senior Biostatistics Director
2 months ago
Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing a wide range of expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries. Our company has a strong foundation as a statistical and data management center of excellence, and we have successfully developed and established ourselves as a full-service CRO.
Job SummaryWe are seeking a highly skilled and customer-focused individual to join our team as Associate Director, Biostatistics (Statistical Operations) 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 Responsibilities- Work with a Director, Senior Director, and/or Executive Director of Biostatistics, Statistical Operations, or Biometrics 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.
- Coach, mentor, develop, provide technical review, and provide advice and expertise to direct subordinate Biostatisticians and Statistical Programmers, as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to the program/projects.
- Perform semi-annual and annual performance review and develop developmental plans for direct subordinates and, where appropriate, indirect subordinates through contributing to the performance evaluation process.
- Lead statistical and programming teams, interact with clients and/or Everest internal project leaders to plan and implement statistical and programming project plans, and deliver quality deliverables.
- Ensure sound statistical methodologies in the study design, sample size estimation, statistical analysis planning, data handling, statistical modeling, testing, analysis, and reporting.
- Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals.
- Serve as a principal level 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 not limited to the following: electronic Case Report Forms (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 (DMP).
- Write Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports (CSRs). Perform peer review of SAPs and other technical documents written by others.
- Perform hands-on statistical analysis and modeling; 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, ensuring that core results for each responsible trial are complete and accurate. Perform overall quality control (QC) review on statistical deliverables before they are released to the clients.
- Review and confirm ADaM dataset specifications. Perform QC 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.
- Act as a consultant to less experienced Biostatisticians.
- 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 generation of performance 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.
- Assist in business development activities, including but not limited to the following: provide cost estimates of statistical and programming services; participate in generation of project proposals and bid defense meetings; and participate in professional trade shows when required.
- Participate and/or assist in statistical and programming project budget planning, tracking, and reporting.
- Perform tracking of out-of-scope services on assigned projects, provide cost estimates, and draft change orders to existing services work orders.
- A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 10 years' relevant experience or a Master's degree in these fields with at least 13 years' relevant experience.
- Demonstrated exceptional ability and performance.
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Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeJob Title: Associate Director, BiostatisticsEverest Clinical Research Services Inc is seeking a highly skilled and experienced Associate Director, Biostatistics to join our team. As a key member of our Biostatistics department, you will be responsible for managing clinical trial programs and projects, providing technical leadership, and ensuring the delivery...
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Senior Biostatistics Director
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Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout Everest Clinical Research Services IncWe are 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.Job SummaryWe are seeking a highly skilled and customer-focused individual to join our team as Associate...
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Senior Biostatistics Director
2 months ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeAbout Everest Clinical Research Services IncWe are 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.Job SummaryWe are seeking a highly skilled and customer-focused individual to join our team as Associate...
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Associate Director Biostatistics
4 weeks ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeJob Title: Associate Director, BiostatisticsEverest Clinical Research Services Inc is seeking a highly skilled and experienced Associate Director, Biostatistics to join our team. As a key member of our Biostatistics department, you will be responsible for managing clinical trial programs and projects, providing technical leadership to project teams, and...
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4 weeks ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeJob Title: Associate Director, BiostatisticsEverest Clinical Research Services Inc is seeking a highly skilled and experienced Associate Director, Biostatistics to join our team. As a key member of our Biostatistics department, you will be responsible for managing clinical trial programs and projects, providing technical leadership, and ensuring the delivery...
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1 month ago
Markham, Ontario, Canada Everest Clinical Research Services Inc Full timeJob Title: Associate Director, BiostatisticsEverest Clinical Research Services Inc is seeking a highly skilled and experienced Associate Director, Biostatistics to join our team. As a key member of our Biostatistics department, you will be responsible for managing clinical trial programs and projects, providing technical leadership, and ensuring the delivery...
