• Principal Biostatistician

    Job Location(s) CN-Beijing | CN-Shanghai | CN-Guangzhou
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  • Job Overview

    • Biostatistics lead for large global or other major projects.
    • Provide statistical input into other disciplines’ activities and participate in interdepartmental processes.
    • Provision of technical solutions and advice to Covance staff and to clients on statistical methodology and principles.
    • Supervision of less-experienced biostatisticians within project activities.
    • Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.
    • Training and development of less-experienced staff within the department
    • 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
    • Develop and coordinate QC procedures for Biostatistics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within specific project.
    • 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 guidance in development of clinical research program and in design of individual studies as part of multi-disciplinary team; responsible for statistical input to protocol; approves protocol as signatory.
    • Provide statistical input into design/review of format of CRFs.
    • 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.
    • Determine documentation requirements for Biostatistics aspects of projects. Give guidance to support business and regulatory requirements including definition of appropriate documentation, storage/communication media, and retention/return of documents at study close-out.
    • Independent peer review of statistical deliverables, e.g., protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listings, statistical reports, Clinical Study Reprots.
    • SAS programming and related activities for the presentation and analysis of clinical trial data.
    • Contribute to review and amendment of departmental processes and supporting documentation.
    • Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.
    • Provide support for special committees, e.g., DMCs, including input/review of charters and ensuring maintenance of appropriate blinding.
    • Contact with client across multiple disciplines.
    • Contribute to proposal activities and client presentations.
    • Represent the department during 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.


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


    • Five years of postgraduate experience in the application of statistics to clinical trials for employees with a PhD in statistics subject; 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
    • Ability to motivate others.
    • The ability to work to tight deadlines while maintaining high standards.
    • SAS proficiency including use of a variety of statistical procedures, e.g. nonparametric analysis, linear and non-linear models, categorical data and survival analysis.
    • Ability to adhere to strict guidelines and codes of practice.
    • A good knowledge of the overall Clinical Trial process and of its application within Covance Clinical Development.
    • Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc., across a variety of trials.
    • Ability to explain statistical concepts to non-statisticians.
    • Supervisory and organizational skills.
    • A proactive approach to management of day-to-day activities and actions that may affect Covance as a business.
    • A professional approach at all times.


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