Senior Statistical Programmer: CDISC & Submissions Expert

Pharmacosmos; Holbæk Kommune; On-site; DKK 1,000,000 - 1,400,000; Full time

Job summary

Pharmacosmos is seeking a Senior Specialist, Statistical Programming to lead sponsor-side statistical programming and CDISC support for regulatory submissions. This role ensures high-quality, inspection-ready deliverables across development programs.

You will oversee outsourced programming, contribute to SDTM/ADaM work, and collaborate with cross-functional teams to drive data-driven decisions while advancing programming standards and regulatory readiness.

Qualifications

• Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, or related field.
• Extensive statistical programming experience in pharma/biotech, 10+ years preferred.
• Strong CDISC (SDTM/ADaM/Define-XML) and regulatory submission expertise.

Responsibilities

• Provide sponsor oversight and quality review of outsourced statistical programming deliverables.
• Ensure SDTM/ADaM/Define-XML datasets meet CDISC standards and regulatory requirements.
• Contribute to clinical trial documentation, regulatory submissions, and inspection readiness.
• Perform statistical programming analyses and support data-driven decision-making.
• Collaborate with cross-functional stakeholders to ensure high-quality outputs.
• Support continuous improvement of programming standards, processes, and best practices.

Skills

SAS programming

CDISC standards

Statistical programming

Regulatory submissions

R or Python

Education

Bachelor's or Master's in Statistics/Math/CS

Tools

SAS

R

Python

Job description

Pharmacosmos is seeking a Senior Specialist, Statistical Programming to lead sponsor-side statistical programming and CDISC support for regulatory submissions. This role ensures high-quality, inspection-ready deliverables across development programs.

You will oversee outsourced programming, contribute to SDTM/ADaM work, and collaborate with cross-functional teams to drive data-driven decisions while advancing programming standards and regulatory readiness.