Senior Biostatistics Director
2 weeks ago
Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing a wide range of expertise-based clinical research services to global pharmaceutical, biotechnology, and medical device industries. We serve some of the most renowned companies and work with many of the most innovative drugs, biologics, and medical devices in development today.
We are seeking a highly skilled and customer-focused individual to join our team as Senior Biostatistics Director 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:
Manage clinical trial programs/projects from one or multiple clients, working closely with a Director, Senior Director, and/or Executive Director of Biostatistics, Statistical Operations, or Biometrics.
Provide day-to-day technical and operational leadership to project teams supporting these programs/projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, data handling, statistical modeling, testing, analysis, and reporting.
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 compliance with relevant regulatory requirements and applicable standards/conventions, participating in the writing of trial protocols and research proposals, and serving as a principal level Biostatistician.
Review and provide input to clinical data management deliverables, including electronic Case Report Forms (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 (CSRs), performing peer review of SAPs and other technical documents written by others.
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 that core results for each responsible trial are complete and accurate.
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, ensuring 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, 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.
Perform statistical and programming resource management, capacity analysis, benchmarking, and generation of performance metrics, contributing to organization development and growth by participating in the interview and evaluation process for professional applicants.
Assist in business development activities, including providing cost estimates of statistical and programming services, participating in generation of project proposals and bid defense meetings, and participating in professional trade shows when required.
Participate and/or assist in statistical and programming project budget planning, tracking, and reporting, performing tracking of out-of-scope services on assigned projects, providing cost estimates, and drafting change orders to existing services work orders.
Qualifications and Experience:
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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