Requirements: English
Company: OPIS
Region: Genoa , Liguria
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 generating 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 developing standard SAS macros and validation documents.Liaise with the Data Management team to develop SAS programs, macros, and utilities to detect data discrepancies.Develop SAS programs for handling external clinical data, including import and reconciliation.Develop and validate programs for identifying Non-Protocol Deviations.Maintain and update SAS programming documentation and SOPs.Stay informed on new SAS developments relevant to clinical data management.Ensure KPI and metrics are met for assigned studies.Complete required trainings and maintain accurate tracking of work hours.Perform additional 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 SAS programming.Understanding 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, and benefits, along with opportunities for professional development within an expanding international company.About Us:OPIS is a global CRO with 25 years of experience in conducting clinical trials across various phases and areas, offering state-of-the-art technology and comprehensive services worldwide.#J-18808-Ljbffr