Sr Principal Biostatistician

Covance Princeton , NJ 08544

Posted 4 months ago

Job Overview

  • Act as statistical consultant for clients and Covance staff.

  • Coordinate biostatistical aspects of submissions to regulatory authorities; participate in presentations to regulatory reviewers.

  • Provide training on biostatistics-related topics to other disciplines.

  • Demonstrate excellent problem solving skills, a proactive approach and the ability to make sound decisions on a regular basis and to communicate these clearly.

  • Provide ongoing guidance and mentoring within the department to ensure thorough knowledge of the processes used and ongoing technical development.

  • Provide support for special committees, e.g., DMCs, including input/review of charters, and ensuring maintenance of appropriate blinding

  • Develop and maintain close working relationships with other disciplines, particularly those who interact closely with Biostatistics

  • Identify and participate in the assessment and implementation of new technologies or of new applications for existing ones.

  • Maintain awareness of new developments in discipline-related techniques, which may be applied to the management and reporting of clinical trial data.

  • Supervision of less-experienced biostatisticians within project activities.

  • 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.

  • Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.

  • 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 Reports.

  • 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.

  • 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.

Education/Qualifications

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

Experience

  • Ten years of postgraduate experience in the application of statistics to clinical trials, preferably with at least one year of statistical project responsibility with a CRO.

  • 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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