SAS Programmer - Clinical Trials Data Specialist

Recordati; Milano; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

Recordati is seeking a skilled Statistical Programmer to drive the programming of outputs (tables, listings, figures) and build SDTM/ADaM datasets for clinical studies. The role involves collaborating with statisticians, data managers, and safety teams to ensure CDISC-compliant deliverables and robust validation of programming utilities.

Ideal candidates have 3–5 years in CRO/pharma settings, strong SAS skills, and familiarity with CDISC and GCP guidelines.

Competenze

• Clear understanding of theoretical and applied statistics and regulatory guidelines in pharmaceutical research; expert in NDA development and submission.

Mansioni

• Program and validate the output (tables, listings, figures) to support data cleaning and statistical analyses.
• Supervise generation of SDTM/ADaM datasets and related documents per CDISC guidelines and CRO outputs.
• Develop standard SAS macros, templates, and utilities with validation documents.
• Interact with the Statistician to prepare tables/listings per specification documents.
• Collaborate with the Data Manager on data cleaning and external data management.
• Coordinate with the Drug Safety Unit to evaluate pharmacovigilance data.
• Lead development, maintenance, and adherence to divisional SOPs and guidelines.

Conoscenze

SAS programming

CDISC standards

Statistical analysis

GCP familiarity

Communication

Formazione

Statistics/Mathematics/Informatics degree

Strumenti

SAS System

R (optional)

SQL (optional)

Descrizione del lavoro

Recordati is seeking a skilled Statistical Programmer to drive the programming of outputs (tables, listings, figures) and build SDTM/ADaM datasets for clinical studies. The role involves collaborating with statisticians, data managers, and safety teams to ensure CDISC-compliant deliverables and robust validation of programming utilities.

Ideal candidates have 3–5 years in CRO/pharma settings, strong SAS skills, and familiarity with CDISC and GCP guidelines.