Senior Statistical Programmer - CDISC & Submissions

Pharmacosmos Group; Holbæk; On-site; DKK 750,000 - 1,100,000; Full time

Job summary

Pharmacosmos A/S is seeking a Senior Specialist, Statistical Programming to lead sponsor-side programming activities. You will ensure SDTM/ADaM datasets, Define-XML submissions, and adherence to CDISC standards across development programs.

You will collaborate with cross-functional teams, support regulatory submissions, and drive continuous improvement of programming standards while maintaining inspection readiness.

Qualifications

• Extensive statistical programming experience in pharma/biotech.
• CDISC standards (SDTM, ADaM, Define-XML) and regulatory submissions expertise.
• Advanced SAS with understanding of clinical development and regulatory requirements.

Responsibilities

• Provide sponsor oversight and quality review of outsourced statistical programming deliverables.
• Ensure datasets and submission deliverables meet CDISC standards and regulatory requirements.
• Contribute to regulatory submissions and inspection readiness.
• Perform statistical programming analyses to support data-driven decision-making.
• Collaborate with cross-functional stakeholders to ensure high-quality trial outputs.
• Drive continuous improvement of programming standards and processes.

Skills

SAS programming

CDISC standards

Regulatory submissions

R

Python

Education

Bachelor's or Master's in Statistics/related field

Tools

SAS

R

Python

Define-XML

Job description

Pharmacosmos A/S is seeking a Senior Specialist, Statistical Programming to lead sponsor-side programming activities. You will ensure SDTM/ADaM datasets, Define-XML submissions, and adherence to CDISC standards across development programs.

You will collaborate with cross-functional teams, support regulatory submissions, and drive continuous improvement of programming standards while maintaining inspection readiness.