Biostatistical Expert for Clinical Trials

3 weeks ago

Markham, Ontario, Canada Everest Clinical Research Full time

Everest Clinical Research is a leading contract research organization providing expert clinical research services to global pharmaceutical, biotechnology, and medical device industries.

We are seeking a highly skilled Biostatistical Expert to join our team at our Markham, Ontario location or remotely from a home-based office in Canada.

This position will support our clients in a Functional Service Provider (FSP) model.

Key Responsibilities:

  1. Leadership and Project Management:
    • Lead efforts in resolving day-to-day work-related issues and problems, securing quality, improving efficiency, and productivity of statistical and programming operations.
    • Lead assigned projects by applying project management skills, statistical, and programming techniques; achieve quality and on-time delivery of deliverables, earn client trust, and repeat business.
  2. Statistical Planning and Methodologies:
    • Provide statistical expertise for design, analysis, and reporting of clinical trials and research projects.
    • Contribute to the writing of statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization codes.
    • Write Statistical Analysis Plans (SAPs) and properly address Peer Statistician review comments.
    • Create and maintain Statistical and Programming Quality Control (QC) and QA Plans for assigned projects.
    • Provide input to unblinded data management plans when required.
    • Assist in research and development of statistical methodologies and processes.
  3. Statistical Programming:
    • Develop and/or review ADaM dataset specifications. Review and provide input to SDTM dataset specifications when required.
    • Perform QC validation of analysis datasets and TLGs.
    • Perform third-level review of dry runs and final runs.
    • Lead statistical dry runs and final runs by actively participating or contributing to project and resources management, addressing statistical and programming questions, and interacting with data management to follow up and resolve data issues.
    • Review and provide input to the Analysis Data Reviewer's Guide, discuss and incorporate Data Standards Reviewer's review comments to ensure quality of the document.
  4. Statistical Analysis and Reporting, and Publication Support:
    • Perform statistical analysis as per SAP, and address peer/QC review comments and findings.
    • Perform statistical validation of core results, address additional QC validation comments and findings on the core results.
    • Plan and conduct or contribute to trial results reporting/dissemination meetings.
    • Under supervision, contribute to contents describing any deviation from the planned analysis and deviation from study conduct for the Clinical Study Report (CSR). Review CSR to ensure accuracy, completeness, and appropriateness of the interpretation of statistical results.
    • Write statistical reports or statistical sections of the CSR.
    • Perform statistical analyses for publications, including but not limited to abstracts, manuscripts, presentations, and posters.
  5. Supporting Clinical Data Collection and Cleaning:
    • Provide statistical input to Case Report Forms (CRF) design and database/variable structure.
    • Provide statistical input to non-CRF data collection and acquisition methods and approaches.
    • Review Data Management Plan sections relating to critical data collection and cleaning. Provide statistical input to Data Validation Specification.
    • Specify and/or program database quality acceptance checks, assess and report data quality issues, and follow through until resolution.
    • Perform ongoing assessment and communication of data quality issues, including protocol deviations.
    • Assist data management and trial management teams in preparing for database lock.
  6. Complete job-required and project-specific training. Comply with applicable Everest and trial sponsor policies, SOPs, and work instructions.
  7. Properly archive study files in accordance with trial sponsor requirements.
  8. Plan and carry out professional development activities.

Qualifications and Experience:

A Ph.D. degree in statistical science, mathematical analysis, or related fields plus 2 years of highly relevant experience or a Master's degree plus 4 years of highly relevant experience, with demonstrated ability and sustained performance.

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