Clinical Data Standards Expert

4 dni temu


Gdańsk, Pomerania, Polska LEO Pharma Pełny etat

Shape the Future of Medical Dermatology

At LEO Pharma, we're pushing the boundaries in medical dermatology worldwide. This role offers a unique opportunity to be part of an ambitious journey, where you'll drive the implementation, design, use, management, and maintenance of clinical data standards and programming standards.

As a Clinical (SDTM) Programmer, your key responsibilities will include:

  • Developing process improvements related to clinical data standards.
  • Spearheading the technical implementation and adoption of clinical data standards.
  • Playing a crucial role in the governance of clinical data and programming standards.
  • Oversight of SDTM data at the trial level, including annotations, specifications, and Reviewer's Guide.
  • Reviewing Case Report Forms (CRF), annotating eCRF to SDTM, reviewing Data Validation Plan (DVP), and creating/reviewing SDTM datasets.
  • Collaborating with Statistical Programming, Clinical Data Management, Biostatistics, and Medical Communication departments.
  • Engaging with external standards development organizations, authorities, CROs, software companies, and professional/scientific contacts.

To excel in this role, you'll need:

  • A diploma in life sciences/statistics/computer science/mathematics or similar.
  • A minimum of 2 years of experience in overseeing SDTM creation, define.xml, annotated CRF, and Clinical Study Data Reviewer's Guides for regulatory submissions.
  • Experience and understanding of programming, as well as a willingness to learn new programs.
  • Experience with CDISC standards and regulatory guidelines.
  • Ability to work collaboratively on various levels of complexity within clinical trial programs.
  • Understanding of regulatory requirements in specific therapeutic areas and their implications for clinical data processing and analysis.
  • Leadership skills to drive projects, timelines, and deliverables within the team.


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