Job responsibilities include:
- Responsible for development of statistical methodology for analysis of study data.
- Responsible for Statistics’ deliverables within assigned projects.
- Perform QC of others team members work.
- Statistical analysis of study data and related decision-making.
- Responsible for statistical input to statistical reports and Study Reports.
- Provide statistical representation on multi-disciplinary team preparing protocol; responsible for statistical input.
- Supervision of less-experienced statisticians within project activities.
- Project management activities for identified projects including resource planning and utilization, timelines and milestone management.
- Take responsibility for overall status and quality of Statistics’ project documentation, including maintenance of hardcopy and electronic files.
- Provide statistical input into other disciplines’ activities and participate in interdepartmental processes.
- Review statistical content of computer validation deliverables.
- Independent peer review of statistical deliverables, e.g., protocols, Summaries and Individual Data Listings, statistical reports, Study Reports.
- Provision of technical solutions and advice to Covance staff and to clients on statistical methodology and principles.
- SAS programming and related activities for the presentation and analysis of study data.
- Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.
- Liaising with external clients over specific requirements.
- 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.
- Conduct all work in compliance with applicable regulatory requirements, and specifically those regulations (GxP) specified in the study plans, protocols, or work agreements governing the work in which they are involved.
– PhD, MA or MS in statistics subject, preferably with a strong medical statistics component. (Alternative academic qualifications are assessed for comparability.)
- 3 to 5 years of postgraduate experience in the application of statistics in the pharmaceutical environment for employees with a PhD in statistics subject; 5 to 8 years of postgraduate experience in the application of statistics in the pharmaceutical environment for employees with an MA/MS in statistics subject
- Effective interpersonal and communication skills.
- 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, mixed models, non-linear models, survival-adjusted tumour incidence models and survival analysis.
- Ability to adhere to strict guidelines & codes of practice.
- A good knowledge of overall drug development process.
- Experience in the preparation of statistical methodology, analysis, reporting, etc.
- Ability to explain statistical concepts to non-statisticians.