An exciting opportunity has arisen to become part of a prominent global pharmaceutical and life sciences organization through a Functional Service Provider (FSP) model. This role is situated within a high-performing global Biometrics team that supports innovative clinical development programs across multiple therapeutic areas. You will collaborate closely with sponsor teams and external partners, offering technical leadership, statistical programming expertise, and oversight of clinical trial deliverables from early development to regulatory submission.

The Role

As a Principal Statistical Programmer, you will lead programming activities across various clinical studies and post-marketing projects, managing statistical programming efforts from study initiation to regulatory submission. This position combines hands-on programming with oversight responsibilities, ensuring high-quality deliverables from both internal programming teams and external CRO partners. You will engage with Biostatistics, Clinical Data Management, Medical Writing, and Regulatory teams while supporting submission activities and continuous process improvements.

Responsibilities

• Lead statistical programming activities across assigned clinical studies.
• Develop and validate SAS programs for ADaM datasets, Tables, Listings & Figures (TLFs), interim analyses, Clinical Study Reports, and post-hoc analyses.
• Perform complex statistical programming for publications, regulatory responses, and exploratory analyses.
• Develop, validate, and maintain CDISC-compliant SDTM and ADaM datasets.
• Support regulatory submission activities, including defining .xml, annotated CRFs, and leading Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) analyses.
• Act as the primary programming contact for assigned studies and oversee programming deliverables from CROs and external vendors.
• Review and approve programming specifications and outputs.
• Review Statistical Analysis Plans (SAPs) for programming feasibility and develop mock shells for TLFs.
• Perform independent QC and validation of datasets and outputs while ensuring compliance with CDISC standards and regulatory expectations.
• Provide technical leadership and mentorship to junior programmers and collaborate with cross-functional study teams.

Requirements

• Master's degree in Statistics, Biostatistics, Bioinformatics, Computer Science (with a statistical focus), or another relevant quantitative discipline.
• 10+ years of statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
• Extensive hands-on experience performing complex statistical analyses within clinical research.
• Proven end-to-end experience developing and validating SDTM datasets, ADaM datasets, and TLFs.
• Strong expertise in SAS for statistical programming and a solid understanding of CDISC standards and regulatory submission requirements.
• Experience reviewing and overseeing programming deliverables from CROs or external vendors.
• Strong communication skills with experience collaborating across global cross-functional teams.

Nice to Have

• Experience with Statistical Analysis Plan (SAP) review and development.
• Development and review of TLF mock shells.
• Advanced SAS macro programming and automation.
• Independent work within SAS Life Science Analytics Framework (LSAF).
• Technical leadership across multiple studies or programs and mentoring junior programmers.
• Experience with regulatory submission documentation and exposure to Define.xml generation tools and Pinnacle 21.
• Experience with R or Python for statistical programming and automation.

What We Offer

• Opportunity to work with a leading global pharmaceutical organization.
• Exposure to high-profile international clinical development programs.
• Fully remote working across multiple European countries.
• 12-month full-time contract with potential for long-term strategic program support.
• Collaborative international environment with highly experienced biometrics professionals.
• Opportunity to influence statistical programming strategy, innovation, and process improvement within a global clinical development organization.