Join our growing team of contract Statistical Programmers across Europe. You will work in our client’s late phase full service group so you will enjoy a varied role working for different sponsors across several therapeutic areas within phases I-IV. The position offers a strong support network, flexible working solutions and the opportunity to progress your career. We are looking for Statistical Programmers from the Pharmaceutical industry, at varying stages of their career to join our contract team.
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 our client’s 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 in a statistical subject is a minimum
* 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