Statistical Operations Manager

1 week ago

Markham, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Description

We are seeking a skilled Statistical Operations Manager to join our team at Everest Clinical Research Services Inc in Toronto/Markham, Ontario, Canada.

About the Role:

As a key member of our Statistical Operations management team, you will be responsible for managing clinical trial programs/projects from one or multiple clients. You will provide day-to-day technical and operational leadership to project teams supporting these programs/projects.

Key Responsibilities:

  • Lead statistical and programming teams and 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 and testing, and 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 Management Plan, and Data Review Plan (and the ongoing data review tables, listings, and figures [TLFs] in accordance with the Plan).
  • Write Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports. Perform peer review of SAPs and other technical documents written by others.
  • Review and confirm ADaM dataset specifications. Perform quality control (QC) activities on ADaM datasets programmed by other Statistical Programmers and Biostatisticians.
  • Perform hands on statistical analysis and modeling; maintain expertise in state-of-the-art statistical methodology and regulatory requirements.
  • Validate core statistical TLFs programmed by Statistical Programmers and/or Biostatisticians, ensuring that core results for each responsible trial are complete and accurate. Perform overall QC review on statistical deliverables before they are released to the clients.
  • 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.
  • Couch, mentor, develop, and provide technical review, advice, and expertise to direct subordinate Biostatisticians and Statistical Programmers, as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to programs/projects.
  • Perform semi-annual and annual performance review and create developmental plans for direct subordinates and, where appropriate, indirect subordinates by contributing to the performance evaluation process.
  • Act as a consultant to less experienced Biostatisticians.
  • Ensure all study level and drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions.
  • 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.
  • 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 service work orders.
Qualifications and Experience:

A Ph.D. degree in statistical science, mathematical analysis, or related fields with at least 5 year's relevant experience OR A Master's degree in the above fields with at least 8 year's relevant experience, with demonstrated exceptional ability and performance.

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