- Act as the Lead Programmer overseeing technical planning for increasingly complex projects including global and multiple study projects, Integrated of Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) and electronic submissions.
- Act as the Biometrics Project Manager for assigned projects.
- 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.
- Review and interpret Statistical Analysis Plans and provide comments for assigned projects.
- Ensure quality of personal work and the work of the programming team when acting as a Biometrics Project Manager and Lead Programmer meeting completions dates with minimal supervision.
- Representing Statistical Programming at internal project team meetings, client meetings and audits.
- Contribute to proposal activities and client presentations providing time and cost estimates for statistical programming activities.
- Perform ongoing review of hours for assigned projects, ensure all issues are highlighted and resolved as quickly as possible and ensure all non-contract tasks are identified, tracked and included in change order forms.
- Provide ongoing supervision, advice and consultation to Lead Programmers and programming team to ensure timely and efficient completion of projects.
- Encourage and participate in the ongoing review of the processes used by the statistical Programming group to ensure processes are continually improved.
- Carry out all activities according to Covance SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP). Ensure adherence to programming guidelines.
- BSc in a computing, life science, mathematical or Statistical subject.
- A high computing content is considered beneficial; however proven computing skills are most important.
- Alternative academic qualifications or experience are assessed to ensure equivalent background.
- 8 years experience in provision of programming support for clinical trial management and reporting, or equivalent experience.
- Extensive experience and proven skills in the development and review of SAS programs within a clinical trials environment.
- Experience in the preparation and review of Statistical Analysis Plans, study set-up and review of study specific documents, e.g. CRF and data validation guidelines.
- Knowledge of all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management.
- Thorough knowledge and understanding of the processes and procedures used within a Statistical Programming environment and the ability to communicate to programmers and non-programmers alike.
- Ability to apply extensive technical expertise and has full knowledge of other related disciplines to provide consultancy and advice on programming and wider related issues to other departments and disciplines.
- Excellent problem solving skills, a proactive approach, anticipating issues and working to ensure they are avoided or resolved as quickly as possible.
- Excellent organizational, time management and project management skills with team leadership experience, as demonstrated by ability to organize and motivate project teams and the ability to delegate and prioritize work to meet project timelines.
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