Senior Statistical Programmer

Location: Via Milano

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.