Senior Statistical Programmer (Biopharmaceutical, Hellerup)

Job summary

This role involves executing statistical programming activities to support clinical data analysis within a biopharmaceutical context, ensuring high-quality deliverables focused on data integrity and timelines.

Qualifications

• Relevant academic degree, preferably a Master’s or PhD, in statistics, mathematics, computer science, engineering, life sciences, or a related field.
• Minimum of 2 years of experience in clinical trials within the pharmaceutical or biotechnology industry, utilizing SAS and/or R.

Responsibilities

• Conduct statistical programming activities to support clinical data analysis.
• Contribute to the development and maintenance of programming standards and code libraries.
• Support metadata-driven statistical programming initiatives.
• Collaborate cross-functionally with international colleagues in a dynamic organization.

Skills

Key competencies

Travel

• Experience in the development and validation of ADaM datasets and TFLs.
• Solid knowledge of regulatory submission standards, including CDISC SDTM, ADaM, Define-XML, ADRG, SDRG, and annotated CRFs.
• Familiarity with Python and knowledge of metadata-driven statistical programming approaches.
• Strong team player with an analytical mindset and a proactive approach to problem-solving.
• Detail-oriented with a focus on quality and compliance.
• Ability to communicate effectively with both technical and non-technical stakeholders.
• Up to 10 days per year.