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    Lead Project Programmer - Ghent, België - Argenx

    Argenx
    Argenx Ghent, België

    1 dag geleden

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    Beschrijving

    We are currently looking for a Lead Project Programmer.

  • The Lead Project Programmer supports biostatisticians and project teamswith cross-project planning ofdiverse statistical/programming tasks and resources, supporting the clinical development programswithin argenx.
  • Providing programming support towards other functional areas within argenx, such as data management, regulatory, global safety, medical.
  • Programming statistical analysis datasets, outputs and performing the QC thereof.
  • Ensuring CDISC compliance of ADaM datasets.
  • Designing, building and improving the statistical programming environment
  • Development of supporting tools

    • The role will report into the Head of Quantitative Sciences.

    ROLES AND RESPONSIBILITIES

  • Manages timelines and in-house programming resources across projects, indications and studies or ad-hoc tasks
  • Participates in project team meetings.
  • Provides relevant input in the development of the CRF, statistical analysis plan andmock tables, listings and figures.
  • Supports outsourcing programming activities and oversees the QC of these activities
  • Develops programs to perform QC of statistical outputs.
  • Performs critical review of derived dataset specifications and derived datasets(ADaM).
  • Defines program specific standards for ADaM datasets. Checks compliance of CROdelivered ADaM datasets to CDISC standards.
  • Verifies (for ADaM's) and ADRG.
  • Develops, validates and documents programs for additional analyses.
  • Develops, reviews, documents and performs validation of generic SAS macros insupport of SAS programming environment.
  • Supports data submission activities according to regulatory guidelines (e.g. ISS, ISE).

    • SKILLS ANDCOMPETENCIES

  • Expertise with diverse statistical software packages such as SAS and ADaM.
  • Thorough knowledge of and experience with CDISC standards.
  • Knowledge of R is a plus.
  • Ability to plan and execute the statistical programming tasks for multiple clinical trials and integrated analyses (e.g., ISS, ISE).
  • Good communication skills and proficiency to work independently and as part of a team.
  • Knowledge of ICH-GCP and other applicable legislation, with good understanding ofclinical data and pharmaceutical development.
  • Experienced wit

    • EDUCATION, EXPERIENCE AND QUALIFICATIONS

  • Bachelors or higher degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
  • Excellent knowledge of SAS and R.
  • Minimum of 10 years of professional experience.
  • Experience in Biotech, in managing CROs and vendors is a plus.
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