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) and/or publications, and/or Health Authorities requestsUse CDISC guidelines to generate SDTM/ADaM datasetsWrite Programming Specifications of analysis datasetsValidate ADaM datasets using Pinnacle 21Prepare, maintain, and archive CDISC documentation for ADaM (Define.xml and ADRG)Contribute to developing standard SAS macros and prepare the corresponding validation documentsLiaise with Data Management team and develop SAS programs/macros and utilities to detect discrepancies in dataCheck requirements to handle external clinical data and develop SAS programs to import/reconcile external clinical dataDevelop and validate SAS programs for identification of Non-Protocol DeviationsCollaborate with Biostatistics and Data Management staff on clinical trials/projectsPrepare, maintain, and archive SAS programming documentationCollaborate in establishing and maintaining standard operating procedures (SOPs) and related forms/templatesCollaborate in establishing and maintaining document/programming standardsKeep informed on new SAS developments relevant to clinical trial data management and promptly update the Direct ManagerEnsure that KPI and metrics for the assigned studies are metPerform and complete required trainings on time (study trainings, OPIS and Sponsor SOPs, etc.)Ensure daily completion of TRACK system, correct entry of billable and non-billable timePerform other tasks as assignedWhat we're looking for :At least 1 year of experience in CRO, biotech, pharma, research institutes in a similar role is preferred. Knowledge of HA requirements pertaining to pharmaceutical research and SAS programming is a plus.Knowledge of statistics and its applications to clinical trialsKnowledge of SAS and CDISC standards (SDTM, ADaM)Planning and organizational skillsTeam-oriented mindsetWhat we offer :We offer a competitive salary, bonuses, and other benefits, along with opportunities for professional development within an expanding and growing international company.Please read the information notice on the processing of personal data in the candidates’ information section of our company website.Who we are :OPIS is an international CRO with 25 years of experience in conducting Phase I-IV, non-interventional, and medical device studies worldwide. We offer state-of-the-art information technology solutions and innovative approaches to meet the increasing complexity and variety of projects.Our expertise spans all phases of drug-related trials, supporting sponsors beyond the therapeutic area, including clinical investigations for medical and diagnostic devices. With global locations, OPIS provides comprehensive clinical research services such as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture, quality assurance, and training.
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