Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK.Our unique approach to data analysis, “The Phastar Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we’re looking for talented individuals who share our passion for quality and technical expertise to join our team.WHY PHASTARAccredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment.What’s more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, you’ll also be helping to save the planet!THE ROLEWe are seeking a Senior Programmer to work across multiple clinical studies;
supporting regulatory submission activities;
producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent knowledge of CDISC SDTM and ADaM implementation guidelines working independently in this area;
producing, reviewing and updating complex dataset specifications (including efficacy);
creating and debugging complex macros;
reviewing Statistical Analysis Plans (SAPs), including study specific ISS / ISE and DSMB SAPs and output shells with a view to commenting from a programming perspective. Excellent team work ethos, proactive at managing workload, willingness to help others and learn new skills from working in a team environment.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 PHASTAR standard specificationsBe an SDTM and ADaM expert providing consultancy, advice and trainingBe an CRT expert providing consultancy, advice and trainingBe aware of up and coming changes to CRT and define.Xml standards and regulatory guidelines and requirementsImplement and coordinate the development and maintenance of PHASTAR CRT toolsBecome familiar with and follow study documentationInitiating projects and ideas for furthering programming developmentEnsure the principles in the PHASTAR checklist are followed rigorouslyDevelop archiving systems and processesAct as a Lead programmer on multiple studies and projects, ensuring quality and timely deliveryLiaise with Study Statistician and Project Manager regarding resourcing and deliverablesResponsible for study level resourcesAttend and input to company resourcing meetingPoint 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 requiredIdentify areas where new processes are requiredCreate, review and update processes and SOPsTake responsibility for study compliance with SOPs and processesQualificationsEducated to BSc or above within Computer Science, Mathematics or a Science related disciplineSAS Programming Experience within the pharmaceutical industryGood awareness of clinical trial issues, design, and implementationExperience of regulatory submissions and associated industry guidanceFamiliarity with GCP and regulatory requirementsKnowledge of SDTM and ADaM CDISC standardsAPPLY NOWWith the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in Spain, France, or Poland as this role can be carried out remotely.Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.J-18808-LjbffrJ-18808-LjbffrJ-18808-Ljbffr
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