Senior Principal Statistician
To Apply Directly: .. - .
This position can be hired Remotely anywhere in US or Canada
- 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.
- MA or MS in statistics subject, preferably with a strong medical statistics component. (Alternative academic qualifications are assessed for comparability.)
- 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.
- 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.