SAS Programmer

Overview

In this role you will program and validate outputs (tables, listings, figures) to support data cleaning and statistical analyses for clinical studies, regulatory and market access requests. You will oversee SDTM/ADaM datasets and related documents, ensuring CDISC compliance and alignment with CRO outputs. You’ll develop SAS macros and templates, and collaborate with statisticians, data managers and pharmacovigilance to maintain SOPs and data standards. This position offers the opportunity to shape statistical programming practices and contribute to regulatory submissions.

Responsabilità Program and validate output (tables, listings, figures) for clinical studies and regulatory/market access requests

Supervise generation of SDTM/ADaM datasets and related documents in CDISC compliance and CRO outputs

Develop standard SAS macros, templates and validation documents

Collaborate with Statistian to prepare tables/listings per specification documents

Interact with Data Manager for data cleaning and external data management

Coordinate with Drug Safety Unit to evaluate pharmacovigilance data

Lead development, maintenance and adherence to divisional SOPs and guidelines

Requisiti fondamentali 3-5 years in a CRO or pharmaceutical company with clinical trials experience

Solid understanding of theoretical and applied statistics and regulatory guidelines in pharma

Expert in development and submission of NDA

CDISC standards knowledge, GCP preferred

Proficiency in SAS System; R and/or SQL as options

collaborative

good communicator

able to interact with all levels of the organization

SAS System programming

CDISC SDTM/ADaM knowledge

SAS macros development