A specialist CRO is looking to hire a Senior Programmer to join them on a permanent basis. Working across clinical and non-clinical studies, you will support regulatory submission activities; produce and validate datasets and outputs whilst adhering to deliverable timelines.Excellent knowledge of CDISC SDTM and ADaM implementation guidelines is required. You will produce, review and update complex dataset specifications (including efficacy); create and debug complex macros; review Statistical Analysis Plans (SAPs), including study specific ISS/ISE and DSMB SAPs and output shells with a view to commenting from a programming perspective.This position is remote (although can be office based or hybrid, depending on your location) and will involve occasional travel to events throughout the year.ResponsibilitiesProgram and validate datasets and SDTMs, including complex efficacy, labs, etc.Become independent technical expertProgram complex non efficacy outputs/ figuresPerform Senior Review and Deliver QC of non- statistical outputBecome involved in developing the standard macro library and take responsibility to implement standard macros within a studyValidate and perform User Acceptance Testing (UAT) on standard macrosIdentify macros requirements, communicate and perform trainingCreate, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc.Implement and coordinate development and maintenance of standard specificationsBe an SDTM and ADAM expert providing consultancy, advice and trainingBe an CRT expert providing consultancy, advice and trainingDevelop archiving systems and processesAct as a Lead programmer on multiple studies and project, ensuring quality and timely deliveryLiaise with Study Statistician and Project Manager regarding resourcing and deliverablesResponsible for study level resourcesPoint of contact for programming issues for the team, proactively ensuring everything is working cohesivelyPersuade stakeholders to follow best practice within a trialDevelop and deliver company-wide training as and when requiredCreate, review and update processes and SOPsQualificationsEducated to BSc or above within Computer Science, Mathematics or a Science related disciplineSAS Programming Experience within the pharmaceutical industryGood awareness of clinical trial design and implementationExperience of regulatory submissions and associated industry guidanceFamiliarity with GCP and regulatory requirementsKnowledge of SDTM and ADaM CDISC standardsFor additional information and a confidential discussion, please apply now with an updated CV.