Job Overview :
Senior Statistical Programmers required to work for Covance
You will be employed by Covance working in our late phase (II-IV) full-service group with the opportunity to work across multiple therapeutic areas
Home based anywhere in Europe or South Africa
You must have previous experience of working as a Principal Statistical Programmer in either a biotech, CRO or pharma company
Candidates must be fluent in English language (both verbal and written)
Join our growing team and discover your extraordinary potential by working as a Covance Principal Statistical Programmer.
You will work in our internal late phase full service group so you will enjoy a varied role working for different sponsors across several therapeutic areas within phases II-IV.
The position offers a strong support network, flexible working solutions and the opportunity to progress your career. This really is an incredibly exciting time to be joining Covance as we continue to grow and expand.
This is a permanent, full-time office or home-based role anywhere within Europe or South Africa.
Job Primary Functions
Perform the role of the Lead Statistical Programmer.Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
Produce Define XML / PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
Develop and / or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Covance and Client standards
Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective
Mentor less-experience programmers in the processes around SDTMs, ADaMs and TFLs ensuring adherence to department practices and processes
Present and share knowledge at department meetings
Respond to QA and client audits and support qualification audits
Contribute to proposal activities and participate in bid defence meetings in order to win new business
Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming
Education / Qualifications :
BSc or BE in a computing, life science, mathematical or statistical subject
Previous experience of being a Lead Statistical Programmer in the CRO or Pharmaceutical industry
Knowledge in 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
Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards
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
Self motivation and ability to work independently without appreciable direction
Ability to apply extensive technical expertise and the 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
A willingness to make decisions seeking advice from statistical programming managers or directors to confirm decisions when necessary
Ability to promote a good team working environment, providing the client with a high quality service while recognizing our business needs
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
PLEASE NOTE CANDIDATES WHO DO NOT FULFIL THE CRITERIA MAY NOT RECEIVE A RESPONSE
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