Requirements: English
Company: OPIS
Region: Pistoia , Tuscany
The Junior Statistical SAS Programmer, under the supervision of the Direct Manager, is primarily responsible for developing SAS programs for generating 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 to generate datasets, tables, figures, and listings for clinical trials, publications, or Health Authorities 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. Collaborate with Data Management to develop SAS programs/macros/utilities for data discrepancy detection. Develop SAS programs to import and reconcile external clinical data. Develop and validate programs to identify 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 required trainings timely. Perform other relevant tasks as assigned. Qualifications: Scientific degree. At least 1 year of experience in CRO, biotech, pharma, or research institutes is preferred. Knowledge of HA requirements related to pharmaceutical research and SAS programming. Understanding of statistics and its application to clinical trials. Proficiency in SAS and CDISC standards (SDTM, ADaM). Fluency in English. Strong planning, organizational, communication, and team-working skills. What We Offer: A competitive salary, bonuses, benefits, and opportunities for professional growth within an expanding international company. About Us: OPIS is a global CRO with 25 years of experience in conducting various phases of clinical trials and studies, offering innovative solutions and comprehensive services worldwide.#J-18808-Ljbffr