Senior Specialist, Statistical Programming

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

Join Pharmacosmos and help drive high-quality clinical development through scientific excellence and data-driven decision-making.

We are looking for an experienced Senior Specialist, Statistical Programming to join our Clinical Development team. In this role, you will act as the sponsor-side expert for statistical programming, CDISC standards, and regulatory submissions, ensuring high-quality, compliant, and inspection-ready clinical trial deliverables across our development programs.

Key Responsibilities

• Provide sponsor oversight and quality review of outsourced statistical programming deliverables.
• Ensure all datasets and submission deliverables (SDTM, ADaM, Define-XML) 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 clinical trial outputs.
• Support continuous improvement of programming standards, processes, and best practices.

Qualifications & Experience

• Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, or a related field.
• Extensive statistical programming experience within the pharmaceutical or biotechnology industry, ideally 10+ years.
• Strong expertise in CDISC standards (SDTM, ADaM, Define-XML) and regulatory submissions.
• Advanced SAS programming skills and a solid understanding of clinical development and regulatory requirements.
• Experience with R, Python, or other programming languages is considered an advantage.

Personal Competencies

You are analytical, detail-oriented, and committed to delivering high-quality results. You work proactively and collaboratively across functions, communicate effectively with stakeholders, and thrive in a dynamic environment where scientific integrity, compliance, and continuous improvement are key.

Why Join Pharmacosmos?

At Pharmacosmos, you will become part of an international and purpose-driven organization dedicated to improving patients' lives through innovative treatments. You will work alongside highly skilled colleagues and contribute directly to clinical development programs that make a meaningful difference to patients worldwide.

For further information about the position, please contact Thomas Delvin, Vice President, Medical Science, at [phone] or [e-mail].

About Pharmacosmos

Pharmacosmos A/S is a global leader in carbohydrate chemistry and innovative treatments for iron deficiency and iron deficiency anaemia. Building on our foundational expertise in carbohydrate chemistry and cell cycle biology, we develop innovative treatments for unmet patient needs, with a focus on iron metabolism and blood-related disorders. Founded in 1965 and headquartered in Denmark, our team is made up of more than 700 specialists across the UK, Ireland, the Nordics, Germany, the USA, and China. Learn more about Pharmacosmos at www.pharmacosmos.com.