Principal Statistical Programmer (Early Phase)
- Experience Level
- Experienced (non-manager)
- Principal Statistical Programmer required to work for Covance within Early Phase
- Excellent opportunities to progress
- Varied, fast paced environment
- Office based in Leeds, Yorkshire, UK or work from home anywhere in Europe or South Africa
- Candidates must have experience of working as a Lead Statistical Programmer within a Biotech, CRO or Pharma company within Europe or South Africa
Join our growing team and discover your extraordinary potential by working as a Covance Principal Statistical Programmer within our Early Phase statistical programming department. As a Principal Statistical Programmer at Covance you will provides technical leadership with responsibility for delivering SAS programming services to clients and project teams, whilst maintaining optimal department processes and implementing effective project specific strategies. The Principal Statistical Programmer will work with the senior team to provide guidance, mentoring and training to Statistical Programmers to ensure best working practices are maintained.
Working within early phase statistical programming we offer, in a word, variety...
In the type of studies: PK, Bioequivalence, Metabolism, Dose Escalation etc. and Sponsors
- In Early Phase we are not assigned for years to the same study, so you will be exposed to multiple studies for clients with different needs as well as working with talented internal colleagues
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
- BSc, preferably in computing, life science, mathematical or statistical subject
- Experience as a lead statistical programmer on complex studies in clinical research
- 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
- 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
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.
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