Principal Statistical Programmer
covance
Barcelona, Spain
hace 5 días

Job Overview :

  • Principal Statistical Programmer required to work for Covance working in Phase I and II oncology
  • Excellent opportunities to progress
  • Varied, fast paced environment
  • Office based in Leeds, Yorkshire, UK or work from home anywhere in Europe
  • Candidates must have experience of working as a Lead Statistical Programmer within clinical research within Europe
  • Join our growing team and discover your extraordinary potential by working as a Covance Principal Statistical Programmer within our Global Clinical Development Statistical Programming department.

    Within this department there is a newly formed team that works solely on Phase I and IIa oncology studies.

    The Principal Statistical Programmer provides technical leadership with responsibility for delivering statistical 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.

    Job Primary Functions

  • Act as a Lead Programmer for projects, and act as a Statistical Programming consultant to clients and internal customers.
  • 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.
  • Develop and review SAS programs and output for SDTMs, ADaMs and TFLs, including submission deliverables e.g. Define XML / PDFs, Reviewers Guides, Analysis Results Metadata (ARM).
  • 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
  • Work proactively to implement process change, working individually or leading a team as appropriate.
  • Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming
  • A comprehensive full job description is available.

    Education / Qualifications :

  • BSc, preferably in computing, life science, mathematical or statistical subject
  • Experience :

  • Candidates must have experience as a Lead Statistical Programmer on complex studies in clinical research
  • Oncology experience desirable but not essential
  • 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
  • You must be fluent in English language (both verbal and written)
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