Senior Statistical Programmer

Senior Programmer / Biostatistician – Global Pharma | North Italy (Hybrid)

Shape the Future of Drug Development

Are you an experienced Statistical Programmer with a strong foundation in statistics and expertise in CDISC standards? Our client, a leading international pharmaceutical company, is seeking a Statistical Programmer / Senior Statistical Programmer to join their collaborative and high-performing team. If you are passionate about delivering high-quality clinical trial data and ensuring regulatory-ready outputs, this could be your next career move.

What You’ll Be Doing

As a key member of the Biometrics team, you will play a critical role in the preparation, validation, and delivery of clinical trial datasets and statistical outputs across all phases of development.

Your responsibilities will include:

• Programming, validating, and maintaining SDTM and ADaM datasets in compliance with CDISC standards.
• Generating Tables, Listings, and Figures (TLFs) to support clinical study reports and regulatory submissions.
• Contributing to the development and review of Statistical Analysis Plans (SAPs) from a programming perspective.
• Ensuring the quality, accuracy, and consistency of all statistical programming deliverables.
• Performing dataset validation and implementing quality control procedures to ensure regulatory compliance.
• Collaborating closely with Biostatisticians, Data Management, Clinical Operations, and external vendors/CROs.
• Supporting regulatory submissions (e.g., FDA, EMA) by preparing submission-ready datasets and documentation.
• Maintaining programming documentation, including specifications and define.xml files.
• Supporting audit and inspection readiness activities.

What We’re Looking For

• Master’s degree in Statistics, Biostatistics, Mathematics, or a related quantitative field (preferred).
• Proven experience in statistical programming within a pharmaceutical company or CRO environment.
• Strong proficiency in SAS (essential); knowledge of R or Python is a plus.
• Hands-on experience with CDISC standards, specifically SDTM and ADaM.
• Experience preparing datasets and outputs for regulatory submissions.
• Solid understanding of clinical trial data structures and clinical development processes.
• Familiarity with define.xml and metadata specifications.
• Experience in oncology or rare disease is an advantage.
• Strong attention to detail and commitment to high-quality deliverables.
• Excellent communication skills and ability to work effectively within cross-functional teams.

Why Join?

• Work within a globally recognised pharmaceutical organisation.
• Contribute to impactful clinical development programs.
• Collaborative and supportive team environment.
• Flexible hybrid working model based in Italy.
• Competitive compensation and long-term development opportunities.

Interested?

Reach out to Aimee directly at to learn more or apply confidentially.