Junior Statistical SAS Programmer

The Junior Statistical SAS Programmer, under the supervision of the Direct Manager, is primarily responsible for developing SAS programs to generate datasets, tables, figures, and listings for clinical studies in accordance with ICH E3 guidelines. The role involves collaboration with Biostatistics and Data Management teams on clinical trials and projects. Key Responsibilities: Develop SAS programs for datasets, tables, figures, and listings for clinical trials, publications, and health authority requests. Utilize CDISC guidelines to generate SDTM and ADaM datasets. Write programming specifications for analysis datasets. Validate ADaM datasets using Pinnacle 21. Prepare, maintain, and archive CDISC documentation such as Define.xml and ADRG for ADaM datasets. Contribute to developing standard SAS macros and validation documents. Liaise with Data Management to develop SAS programs/macros/utilities for data discrepancy detection. Develop SAS programs for handling external clinical data, including import and reconciliation. Develop and validate programs for identifying Non-Protocol Deviations. Maintain SAS programming documentation and SOPs. Stay informed on new SAS developments relevant to clinical trial data management. Ensure KPI and metrics are met and complete all required trainings timely. Perform daily updates in the TRACK system, accurately recording billable and non-billable time. Perform other assigned tasks as needed. Qualifications: Scientific degree. At least 1 year of experience in CRO, biotech, pharma, or research institutes (preferred). Knowledge of HA requirements related to pharmaceutical research and SAS programming. Knowledge of statistics and its application to clinical trials. Proficiency in SAS and CDISC standards (SDTM, ADaM). Fluent in English. Strong planning, organizational, communication, and team-working skills. What We Offer: A competitive salary, bonuses, benefits, and opportunities for professional development within an expanding international company. About Us: OPIS is an international CRO with 25 years of experience in clinical research, offering innovative IT solutions and comprehensive services across all trial phases worldwide. J-18808-Ljbffr

Location: caserta, IT

Posted Date: 6/1/2025