Principal Statistical Programmer - Europe - Office or Home Based

  • Madrid
  • Worldwide Clinical Trials
What you will do Serve as a programming project lead on multiple complex studies (e.g. adaptive design, integrated safety/efficacy study) to distribute and oversee tasks for the programming team, communicate with internal and external clients, plan and execute delivery, and manage resources, competing project priorities and client's expectations effectively. Ensure budget and scope of project work remain aligned. Apply advanced knowledge of CDISC standards and electronic data submission (SDTM annotated CRF, define.xml, Study/Analysis Data Reviewer's Guide, Analysis Results Metadata). Provide expertise and consultancy on FDA, PMDA and other regulatory agencies submission requirements. Take full ownership of department process improvement projects and initiatives including development of standard SAS Macros, in-house programming standards Develop and provide Statistical Programmers, Biostatisticians and representatives of other departments and groups with training and coaching on the Biostatistical Operations department process, infrastructure and tools, collaboration with other internal and external parties and the role of the statistical programmer. What you will bring to the role Must be computer literate and numerate with a willingness to adapt to various computer systems. Hands-on expert level project statistical programmer experienced in providing programming leadership to projects. Statistical programming skills and knowledge across a broad range of applications together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change. The job holder must have a depth of expertise across all statistical programming skills and consistently display a positive attitude and considered as a global role model. It is essential that the job holder to possess strong analytical skills and attentiveness to detail. Expert in upstream (Data Management) and downstream (Medical Writing, regulatory submission) processes. To have the ability to train new staff and to monitor their performance. Your experience University Degree or equivalent (post-graduate degree is preferable, but not mandatory). Advanced SAS programming skills with expert knowledge in SAS/Macro, Proc Report and ODS. Good working knowledge in SAS/Graph, Proc SQL, SAS/STAT. Previous experience in process improvement, development and deployment of innovation.