Who we are looking forPurposeTo develop programs and statistical output for the management and reporting of clinical trial data managed by Global Clinical Department.
To guarantee quality of statistical output produced by external provider, to program tools to support data review activities and data visualization, to collaborate on the interpretation and communication of trial results.
Main Responsibilities• To convert data to CDISC SDTM, following project specifications and to check the adherence versus CDISC Implementation Guides and company libraries• To develop programs to generate analysis datasets (CDISC compliant)• To produce datasets documentation according to CDISC and FDA requirements (define.xml) and/or to review analysis datasets documentation prepared by providers• To develop programs to produce tables, listings, and figures as planned in the statistical analysis plan and to support data review activity before database lock• To perform QC of the programming material prepared by external providers guaranteeing the output provided is correct and in line with International requirements and with internal SOP/Standards Experience RequiredAt least 1 year experience as Statistical Programmer in CROs or Pharmaceutical industriesEducationUniversity Degree in StatisticsLanguagesEnglish fluentTechnical Skills• Base knowledge in SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/ACCESS, and SAS/ODS on Windows environment.• Involved in clinical data analysis and preparation of Data sets, Reports, Tables, Listings, Summaries and Graphs according to Standard Operating Procedures (SOPs).• Knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM), Analysis Dataset Models (ADaM), Operational Data Model (ODM) and Case Report Tabulation Data Definition Specification (Define.xml).• General knowledge of statistical methods• Knowledge of R, Phyton or any other open source tool for the data analysis and data visualizationSoft SkillsAnalytical skillsCommunication skillsQuality orientationTeam workingProblem solvingWhat we offerYou would join a dynamic, fast-growing, challenging and friendly environment.In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development.
Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best.
That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
