Covance Senior Biostatistician in Tallahassee, Florida

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.

Job Number 2018-22866

Job Category Other

Position Type Full-Time

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