SDTM Programmer Lead

1 tydzień temu

Gdańsk, Pomerania, Polska LEO Pharma Pełny etat

The Power of Collaboration

We believe in teamwork and the potential of every individual at LEO Pharma. This role is your gateway to becoming part of a company that's making a real difference in the world of pharmaceuticals.

In this position, you'll facilitate and promote the implementation, design, use, management, and maintenance of clinical data standards and programming standards from protocol development to regulatory submission.

Your primary responsibilities will include:

  • Implementing process improvements related to clinical data standards.
  • Supporting the technical implementation and adoption of clinical data standards.
  • Playing an active role in the governance of clinical data and programming standards.
  • Overall responsibility for 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 succeed in this role, you should have:

  • A degree in life sciences/statistics/computer science/mathematics or a related field.
  • Minimum 2 years of experience in overseeing SDTM creation, define.xml, annotated CRF, and Clinical Study Data Reviewer's Guides for regulatory submissions.
  • Programming knowledge and a willingness to learn new technologies.
  • CDISC standards and regulatory guidelines expertise.
  • Strong communication skills for collaboration with cross-functional teams.
  • Ability to lead projects, drive timelines, and deliverables within the team.

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