Requirements: English
Company: OPIS
Region: Parma , Emilia-Romagna
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.Some of what you''ll do:Develop SAS programs for generating datasets, tables, figures, and listings for clinical trials (according to ICH E3), publications, and/or 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 the corresponding validation documents.Liaise with Data Management team and develop SAS programs/macros/utilities to detect discrepancies in data.Handle external clinical data and develop SAS programs to import/reconcile this data.Develop and validate SAS programs for identification of Non-Protocol Deviations.Collaborate on clinical trials/projects with Biostatistics and Data Management staff.Maintain and archive 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 for assigned studies are met.Complete all required trainings timely.Perform daily updates in the TRACK system, including correct entry of billable and non-billable time.Perform other tasks as assigned.What we''re looking for:Scientific degree.At least 1 year of experience in CRO, biotech, pharma, 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).Fluency in English.Planning and organizational skills.Strong communication skills.Team-oriented attitude.What we offer:We offer a competitive salary, bonuses, and other benefits, along with opportunities for professional development within an expanding international company.Please review the information notice on personal data processing available on our website.Who we are:OPIS is an international CRO with 25 years of experience conducting Phase I-IV, non-interventional, and medical device studies worldwide. We leverage state-of-the-art technology and innovative approaches to manage complex projects across all phases of drug development, including clinical investigations for medical and diagnostic devices. Our global locations enable us to provide comprehensive clinical research services, including scientific advice, medical writing, trial start-up, monitoring, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture, quality assurance, and training.#J-18808-Ljbffr