- Principal Statistical Programmers required to work for Covance as a Lead on complex studies in Phases I-IV
- You will be employed by Covance and work within our FSPx department 100% dedicated to one Sponsor
- Office based in in any of our European offices or home based anywhere in Europe
- You must have previous Lead experience as a Statistical Programmer within a biotech, CRO or pharma company
- Oncology experience would be an advantage but not essential
- Opportunities to develop and progress
Discover new opportunities to grow your career as a Covance FSP Principal Statistical Programmer. Covance FSP are looking to hire experienced Lead Statistical Programmers.
Our partner, a global pharma company has an incredibly exciting and strong pipeline with circa 40 ongoing studies across various therapeutic areas including; infectious diseases, immunology, nephrology, oncology, ophthalmology and urology across Phases I to IV. The position offers a strong support network, flexible working solutions and the opportunity to progress your career. If you are looking to strengthen your Lead expertise whilst gaining exposure to a pharmaceutical working environment this is a fantastic opportunity.
This is an incredibly exciting time to be joining Covance as we continue to grow and expand. This is a full-time home or office-based role anywhere within Europe or South Africa. What is FSP?
At Covance, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).
As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise.
Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Covance studies.
With the support of exceptional people and an energized purpose, you'll be empowered to own your career journey with dedicated mentoring, training and personalized development planning. Further information can be found at: https://www.covance.com/services/functional-service-provision.html 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 defenses meetings in order to win new business
- Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming
- BSc in a computing, life science, mathematical or statistical subject
- Previous Lead experience as a Statistical Programmer on complex studies within a biotech, CRO or pharma company
- 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
- Candidates must be fluent in English language (both verbal and written)
PLEASE NOTE CANDIDATES WHO DO NOT FULFIL THE CRITERIA MAY NOT RECEIVE A RESPONSE
NO AGENCIES PLEASE MORE INFORMATION AVAILABLE ON REQUEST
For a confidential discussion about this opportunity, please phone Peter Lewis on +44 (0) 1628 543 457 . To apply, please click on the APPLY button. Keywords:
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