Senior Specialist, Statistical Programming

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

Senior Specialist, Statistical Programming

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.

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.