Requirements: English
Company: OPIS
Region: Lucca , Toscana
The Junior Statistical SAS Programmer, under thesupervision of the Direct Manager, is mainly involved in developingSAS programs for the generation of datasets, tables, figures andlistings for clinical studies (according to ICH E3), publicationsor Health Authorities requests. Collaborates with Biostatistics andData Management staff on clinical trials/projects. Some of whatyou''ll do: - Develop SAS programs for generating datasets, tables,figures and listings for clinical trials (according to ICH E3)and/or publication, and/or Health Authorities requests - Use CDISCguidelines to generate SDTM/ADaM datasets - Write ProgrammingSpecifications of analysis datasets - Validate ADaM datasets usingPinnacle 21 - Prepare, maintain, and archive CDISC documentationfor ADaM (Define.xml and ADRG) - Contribute to developing standardSAS macros and prepare the corresponding validation documents -Liaise with Data Management team and develop SAS programs/macrosand utilities to detect discrepancies in the data - Check therequirements to handle external clinical data and develop the SASprograms to import/reconcile external clinical data - Develop andvalidate SAS programs for identification of Non-Protocol Deviations- Collaborate with Biostatistics and Data Management staff onclinical trials/projects - Prepare, maintain and archive SASprogramming documentation - Collaborate in establishing andmaintaining standard operating procedures (SOPs) and correspondingforms/templates related to Statistical SAS programming -Collaborate in establishing and maintaining document/programmingstandards - Keep informed on new SAS developments relevant to theclinical trial data management promptly updating the Direct Manager- Ensure that KPI and metrics for the assigned studies are met -Perform and complete on time all required trainings (studytrainings, training on OPIS and/or Sponsor SOPs, all otherapplicable trainings) by the assigned due date - Ensure dailycompletion of TRACK system, correct entry of appropriate billableand non-billable time - Perform other tasks as assigned What we''relooking for: - Scientific degree - At least 1 year of experience inCRO, biotech, pharma, research institutes in similar role ispreferred Knowledge of HA requirements pertaining to pharmaceuticalresearch and specifically to SAS programming - Knowledge instatistics and its applications to clinical trials - Knowledge ofSAS and CDISC standards (SDTM, ADaM) - Fluent in English - Planningand organizational skills - Communication skills - Team-workingoriented What we offer: We offer a competitive salary, bonuses, andother benefits together with the opportunity to develop yourprofessional career with an expanding and growing internationalcompany. Please read the information notice on the processing ofpersonal data in the candidates information section of our companywebsite. Who we are: OPIS is an International CRO with 25 years ofexperience in conducting Phase I-IV, non-interventional and medicaldevices studies on an international level. We always offerstate-of-the-art information technology solutions and innovativeapproaches to the increasing complexity and variety of projects.OPIS extensive expertise covers all phases of drug-related trials,taking care of the Sponsor beyond the therapeutic area, offeringalso accurate clinical investigations for medical and diagnosticdevices. With Global Clinical Research Locations all over theworld, OPIS offers a full range of integrated clinical researchservices as scientific advice, medical writing, trial start-up,monitoring, study management, data management, statistics,pharmacovigilance, medical monitoring, electronic data capture aswell as quality assurance and training.