Covance

  • Senior Biostatistician

    Job Location(s) US-NC-Raleigh-Durham | US-Nationwide | US-NJ-Princeton | US-MA-Boston | US-CA-San Francisco | US-TX-Austin | US-CA-Livermore | US-NC-Raleigh-Durham
    Job Number
    2018-22866
    Job Category
    Other
    Position Type
    Full-Time
  • Job Overview

    • Responsible for development of Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data–handling rules and mockups.
    • Responsible for Biostatistics’ deliverables within assigned projects.
    • Perform QC/statistical review of all analysis datasets and data displays.
    • Statistical analysis of clinical trial data and related decision-making.
    • Responsible for statistical input to statistical reports and Clinical Study Reports. Authorizes final reports as one of Covance signatories.
    • Provide statistical representation on multi-disciplinary team preparing protocol; responsible for statistical input; approves as signatory.
    • Provide statistical input into design/review of format of CRFs.
    • Supervision of less-experienced biostatisticians within project activities.
    • Prepare randomization specifications; generate schedules; verify randomization components (specification and schedule). Provide input into planning activities related to the preparation of, distribution of and access to randomization and unblinding information.
    • Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.
    • Take responsibility for overall status and quality of Biostatistics’ project documentation, including maintenance of hardcopy and electronic files.
    • Provide statistical input into other disciplines’ activities and participate in interdepartmental processes.
    • Independent peer review of statistical deliverables, e.g., protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listings, statistical reports, Clinical Study Reports.
    • Provision of technical solutions and advice to Covance staff and to clients on statistical methodology and principles.
    • Provide support for DMCs, ensuring maintenance of appropriate blinding.
    • SAS programming and related activities for the presentation and analysis of clinical trial data.
    • Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.
    • Contact with client across multiple disciplines.
    • Assigned tasks related to the development of less-experienced staff within the department.
    • Contribute to review and amendment of departmental processes and supporting documentation.
    • Contribute to proposals activities and client presentations.
    • Represent the department during project-driven client audits.
    • Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP.
    • Perform other duties as requested by management.

     

    Education/Qualifications

    • MA or MS in statistics subject, preferably with a strong medical statistics component. (Alternative academic qualifications are assessed for comparability.)

    Experience

    • 3 to 5 years of postgraduate experience in the application of statistics to clinical trials for employees with a PhD in statistics subject; 5 to 8 years of postgraduate experience in the application of statistics to clinical trials for employees with an MA/MS in statistics subject
    • Interpersonal and effective communication skills.
    • Cooperative, team-oriented and proactive.
    • Self-motivation.
    • The ability to work to tight deadlines while maintaining high standards.
    • SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis.
    • Ability to adhere to strict guidelines & codes of practice.
    • A good knowledge of the overall clinical trial process.
    • Experience in the preparation of Statistical Analysis Plans, analysis, reporting, etc.
    • Ability to explain statistical concepts to non-statisticians.
    • Organizational skills.
    • An evident appreciation of the possible impact of day-to-day activities and actions on Covance as a business.
    • A professional approach at all times.

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