- 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.
- 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.
Senior Statistical Programmer - Ficarazzelli-Bagni Italia - Warman O'Brien
Descrizione
Senior Programmer / Biostatistician – Global Pharma | North Italy (Hybrid)
Shape the Future of Drug Development
Scopra se questa opportunità è adatta a lei leggendo tutte le informazioni riportate di seguito.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:
What We're Looking For
Interested? xivgfpx
Reach out to Aimee directly at to learn more or apply confidentially.