Senior Statistical Programmer

Working as a Senior Statistical Programmer in our Lausanne, Paris, or Cambridge UK office, you will use your advanced SAS programming expertise and in-depth knowledge of industry-wide standards to lead and support clinical studies across all phases of development.Reporting to the Director of Biostatistics, you will work closely with a small group of Biostatistician-Programmers to lead and support key aspects of the programming effort, ensuring the successful delivery of data and reporting components for various projects.Responsibilities include, but are not limited to, the following:Advanced SAS Programming ExpertiseProficient in Base SAS, SAS/Macro, SAS/SQL; experience with SAS/Graph is a plusDemonstrated ability to develop, maintain, and troubleshoot SAS macro librariesStrong Knowledge of CDISC StandardsHands-on experience with the implementation of SDTM and ADaM datasetsExperience in Define-XML creation and CDISC validation tools such as Pinnacle 21Regulatory Reporting ExperienceDirect involvement in generating outputs for periodic regulatory submissions (e.g., DSURs, PSURs, Annual Safety Reports)Working knowledge of FDA and EMA submission requirementsLead and Validation ProgrammingExperience leading programming efforts for the creation and validation of SDTM and ADaM datasets and statistical outputs (tables, listings, figures)Ability to conduct and document independent validation of programming deliverablesStandardization of OutputsProven track record in building and maintaining a suite of standardized, reusable outputs and templates to support multiple studiesCollaborative and Communication SkillsComfortable working cross-functionally with statisticians, data managers, and clinical teamsStrong documentation practices and the ability to communicate technical concepts clearlyQuality and Compliance FocusCommitment to Good Programming Practices (GPP) and regulatory complianceStrong attention to detail and thorough understanding of QC processes in a clinical trial settinBachelor’s or master\’s degree in Statistics, Computer Science, Engineering, or a related fieldMinimum of 5 or more years of experience in clinical trial programming within the pharmaceutical, biotech, or CRO industryAdvanced knowledge and experience in:SAS programming: experience in R is a major assetCDISC standards (e.g., CDASH, SDTM, ADaM) and industry best practicesTechnical and regulatory requirements related to the roleDatabase set-upClinical drug developmentProficiency in English – conversational French would be a plus #J-18808-Ljbffr