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In this role, the selected candidate will develop SAS programs for SDTM, ADaM, client-defined analysis datasets, Patient Profiles, Tables, Listings and Graphs in support of the Statistical Analysis Plan, posters, manuscripts, Integrated of Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). Additionally, you will provide technical planning to include overseeing the set-up of key macros and SAS program; act as a Lead Programmer for projects; represent Statistical Programming at internal and client meetings; act as a Statistical Programming consultant to clients and internal customers in related disciplines e.g. Clinical Data Management, Project Management and Medical Writing.
- Develop SAS programs for SDTM, ADaM, client-defined analysis datasets, Patient Profiles, Tables, Listings and Graphs in support of the Statistical Analysis Plan, posters, manuscripts, Integrated of Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
- Provide technical planning to include overseeing the set-up of key macros and SAS programs.
- Act as a Lead Programmer for projects.
- Represent Statistical Programming at internal and client meetings.
- Act as a Statistical Programming consultant to clients and internal customers in related disciplines e.g. Clinical Data Management, Project Management and Medical Writing.
- Demonstrate excellent problem-solving skills, a proactive approach and a willingness to make decisions on a regular basis.
- Ensure quality of personal work and the work of the team when acting as a Lead Programmer.
- Prioritize personal workload and that of teammates; perform work with minimal supervision.
- Work on complex problems where analysis of situations or data requires an evaluation of intangible variables; development of technical solutions to abstract problems which require the use of ingenuity and creativity.
- Advise Senior Statistical Programming Staff of changes in scope of projects to enable the timely development of change orders.
- Good experience with CDISC standards including Define.xml files.
- Display a positive attitude at all times, promoting and contributing to good team spirit in a professional environment.
- Review draft and final production runs for project to ensure quality and consistency.
- Represent Statistical Programming during client audits ensuring study documentation is maintained and filed according to Covance processes.
- Assist with interviewing and selection of potential candidates.
- Carry out all activities according to Covance SOPS working within the framework of the Quality management System and to Good Clinical Practice (GCP).
- Provide ongoing training and mentoring within Statistical Programming to ensure thorough knowledge of the processes used and the ongoing technical development.
- BSc in a computing, life science, mathematical or statistical subject.
- A high computing content is considered to be beneficial; however proven computing skills are most important.
- Alternative academic qualifications or experience are assessed to ensure equivalent background.
- 5-8 years experience with proven SAS skills within a clinical trials environment.
- Knowledge in all aspects of clinical trials from initial study set-up to study completion.
- Full knowledge and understanding of the processes and procedures used within a Statistical Programming environment.
- Able to identify training and development needs, opportunities for optimizing staff utilization and employing the most efficient practices.
- Excellent organizational skills and the ability to delegate and prioritize work to meet tight deadlines while maintaining high standards.
- Self motivation and ability to work independently with minimum direction.
- Excellent time management skills and the ability to work to tight deadlines whilst maintaining the highest standards of work.
- Good interpersonal skills and the ability to communicate appropriately withal levels of staff and confidently with other disciplines and external clients.
- A proactive approach to developing and maintaining effective working relationships with staff in other disciplines, often in other locations and in working to achieve consistent processes and standards across them.
- A co-operative and team orientated approach.
- Team leadership experience, as demonstrated by ability to organize and motivate project teams.