Requirements: English
Company: OPIS
Region: Arezzo , Tuscany
The Junior Statistical SAS Programmer, under the supervision of the Direct Manager, is primarily involved in developing SAS programs for generating datasets, tables, figures, and listings for clinical studies according to 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, or Health Authorities requests.Use 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 the development of standard SAS macros and their validation.Collaborate with Data Management to develop SAS programs/macros/utilities for data discrepancy detection and external data handling.Develop and validate SAS programs for identifying Non-Protocol Deviations.Maintain SAS programming documentation and contribute to SOPs and standards.Stay informed on new SAS developments relevant to clinical trial data management.Ensure KPI and metrics are met, and complete required trainings on time.Perform daily tracking and data entry in the system.Perform other assigned tasks as needed.Requirements:Scientific degree.At least 1 year of experience in CRO, biotech, pharma, or research institutes in a similar role (preferred).Knowledge of HA requirements related to pharmaceutical research and SAS programming.Knowledge of statistics and clinical trials applications.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 a growing international company.About Us:OPIS is an international CRO with 25 years of experience in clinical research, offering innovative solutions and comprehensive services worldwide.#J-18808-Ljbffr