Requirements: English
Company: OPIS
Region: Verona , Veneto
The Junior Statistical SAS Programmer, under the supervision of the Direct Manager, is mainly involved in developing SAS programs for the generation of datasets, tables, figures, and listings for clinical studies (according to ICH E3), publications, or Health Authorities requests. Collaborates with Biostatistics and Data Management staff on clinical trials/projects.Responsibilities:Develop SAS programs for generating datasets, tables, figures, and listings for clinical trials (according to ICH E3), publications, and Health Authorities requests.Use CDISC guidelines to generate SDTM / ADaM datasets.Write Programming Specifications of analysis datasets.Validate ADaM datasets using Pinnacle 21.Prepare, maintain, and archive CDISC documentation for ADaM (Define.xml and ADRG).Contribute to developing standard SAS macros and prepare validation documents.Liaise with Data Management team to develop SAS programs/macros/utilities to detect data discrepancies.Handle external clinical data requirements and develop SAS programs to import/reconcile external data.Develop and validate SAS programs for identifying Non-Protocol Deviations.Collaborate on clinical trials/projects with Biostatistics and Data Management staff.Maintain SAS programming documentation.Establish and maintain SOPs and related templates for Statistical SAS programming.Stay informed on new SAS developments relevant to clinical trial data management.Ensure KPI and metrics are met for assigned studies.Complete required trainings on time.Accurately complete daily entries in the TRACK system.Perform other tasks as assigned.Qualifications: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 its applications to clinical trials.Proficiency in SAS and CDISC standards (SDTM, ADaM).Fluent in English.Strong planning and organizational skills.Good communication skills.Team-oriented attitude.What We Offer:Competitive salary, bonuses, and benefits, along with opportunities for professional development within an expanding international company.About OPIS:OPIS is an international CRO with 25 years of experience in conducting Phase I-IV, non-interventional, and medical device studies globally. We provide state-of-the-art IT solutions and innovative approaches to complex projects, covering all phases of drug-related trials and offering comprehensive clinical research services worldwide.#J-18808-Ljbffr