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Senior Statistical Programmer

hace 2 meses

Madrid, Madrid, España Mai Fortrea Development A tiempo completo
About the Role

Mai Fortrea Development is seeking a highly skilled Senior Statistical Programmer to join our team in the Oncology Clinical Trials department. As a key member of our team, you will be responsible for developing and validating SAS programs for data presentations and analyses, and providing programming support to our global project team.

Key Responsibilities
  • Review and advise on the development of complex TFL shells from a programming perspective
  • Develop and lead the development of complex specifications for SDTMs and ADaM datasets
  • Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform quality control of SDTM, ADaMs and TFLs
  • Produce and define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
  • Respond to QA and client audits and support qualification audits
  • Identify and propose innovative ways to improve the efficiency, quality and productivity of our clinical statistical programming business
  • Maintain awareness of industry standards, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs)
Requirements
  • Degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
  • Solid professional experience as a statistical programmer within a biotech, CRO or pharmaceutical company
  • Demonstrated knowledge of base SAS, SAS macros, SAS/STAT; demonstrated ability to debug SAS programs
  • Proven professional experience with SDTMs, ADaM datasets (safety and efficacy) and TFLs
  • Solid knowledge of CDISC standards
  • Prior experience working on oncology data (safety and efficacy) and/or on vaccine trials
  • Submission experience is ideal
  • Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail
  • Business fluency in English both spoken and written is a must