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, or Health Authorities requests.Use CDISC guidelines to generate SDTM / ADaM datasets.Write Programming Specifications for 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 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 it.Develop and validate SAS programs for identifying Non-Protocol Deviations.Collaborate with Biostatistics and Data Management staff on clinical trials/projects.Maintain and archive SAS programming documentation.Assist in establishing and maintaining SOPs and related templates for Statistical SAS programming.Keep informed on new SAS developments relevant to clinical trial data management and update the Direct Manager.Ensure KPI and metrics for assigned studies are met.Complete required trainings on time (study trainings, OPIS, Sponsor SOPs, etc.).Maintain daily completion of TRACK system, including correct entry of billable and non-billable time.Perform other tasks as assigned.What we're looking for :At least 1 year of experience in CRO, biotech, pharma, or research institutes in a similar role is preferred. Knowledge of HA requirements related to pharmaceutical research and SAS programming is desirable.Knowledge of statistics and its applications to clinical trials.Proficiency in SAS and CDISC standards (SDTM, ADaM).Planning and organizational skills.Team-oriented mindset.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 globally. We leverage state-of-the-art technology and innovative approaches to meet project complexities.Our expertise spans all phases of drug-related trials, supporting sponsors beyond therapeutic areas, including clinical investigations for medical and diagnostic devices. With global locations, OPIS provides 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