Senior Statistical Programmer

il y a 7 jours


Paris, Île-de-France SEC Life Sciences Temps plein

Unlock Your Potential in Clinical Trials

As a Senior Statistical Programmer at SEC Life Sciences, you will play a key role in delivering phases I-III of complex clinical trials for global pharmaceutical leaders. Your expertise will be instrumental in supporting regulatory submissions and driving the development of life-changing treatments.

Working with a diverse, global team, you'll have the chance to lead studies through various stages of clinical development and contribute to the creation of benchmark drugs in a variety of therapeutic areas. Your work will directly impact patient health worldwide.

This position offers the flexibility to work remotely from anywhere in EMEA or from one of our offices throughout Europe, and you'll benefit from a flexible and supportive environment that promotes a genuine work-life balance and offers competitive compensation for your contract role.

Your Key Responsibilities

  • Review statistical analysis plans (SAPs) and tables, listings, and figures (TFL) shells from a programming perspective
  • Offer programming insights into the development of complex TFL shells
  • Lead and develop specifications for SDTM and ADaM datasets, ensuring accuracy and alignment with project needs
  • Create and maintain SAS programmes for generating SDTM and ADaM datasets, as well as TFLs
  • Perform quality control for SDTM, ADaM datasets, and TFLs to ensure compliance with industry standards
  • Produce and define XMLs, PDFs, and Analysis Results Metadata (ARM), as well as annotated CRFs and Reviewers' Guides
  • Assist with client and QA audits, responding to feedback and supporting audit processes
  • Identify and suggest improvements to statistical programming processes to enhance efficiency, quality, and output
  • Keep updated on industry standards, global regulatory requirements, and internal SOPs to maintain best practices

Requirements for the Role

  • Degree in mathematics, life sciences, statistics, computer science, or a related field (or equivalent vocational training/professional experience)
  • Substantial experience as a statistical programmer in the biotech, CRO, or pharmaceutical sectors
  • Strong proficiency in SAS programming, including SAS macros and SAS/STAT, with the ability to troubleshoot and debug code effectively
  • Expertise in creating SDTM and ADaM datasets (both safety and efficacy), along with TFL generation
  • Solid understanding of CDISC standards, including SDTM and ADaM guidelines
  • Previous experience with submission processes is highly desirable
  • A proactive approach to learning and improving within a dynamic, fast-paced environment

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