We are seeking a Sr. Principal Biostatistician to act as statistical consultant for clients and Covance staff; coordinate biostatistical aspects of submissions to regulatory authorities; participate in presentations to regulatory reviewers; and provide training on biostatistics-related topics to other disciplines.
The selected candidate will:
- 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.
- Covance is an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.