Overview
Work as a principal programmer across multiple clinical and non-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.
Responsibilities
Employees may be required to perform some or all of the following:· Program and validate datasets and SDTMs, including complex efficacy, labs, etc.· Become independent technical expert· Program complex non efficacy outputs/ figures· Perform Senior Review and Deliver QC of non- statistical output· Become involved in developing the standard macro library and take responsibility to implement standard macros within a study· Validate and perform User Acceptance Testing (UAT) on standard macros· Identify macros requirements, communicate and perform training· Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc· Implement and coordinate development and maintenance of PHASTAR standard specifications· Be an SDTM and ADAM expert providing consultancy, advice and training· Be an CRT expert providing consultancy, advice and training· Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements· Implement and coordinate the development and maintenance of PHASTAR CRT tools· Become familiar with and follow study documentation· Initiating projects and ideas for furthering programming development· Ensure the principles in the PHASTAR checklist are followed rigorously· Develop archiving systems and processes· Act as a Lead programmer on multiple studies and project, ensuring quality and timely delivery· Liaise with Study Statistician and Project Manager regarding resourcing and deliverables· Responsible for study level resources· Attend and input to company resourcing meeting· Point of contact for programming issues for the team, proactively ensuring everything is working cohesively· Persuade stakeholders to follow best practice within a trial· Develop and deliver company-wide training as and when required· Identify areas where new processes are required· Create, review and update processes and SOPs· Take responsibility for study compliance with SOPs and processes
Qualifications
· Educated to BSc or above within Computer Science, Mathematics or a Science related discipline· SAS Programming Experience within the pharmaceutical industry· Good awareness of clinical trial issues, design, and implementation.· Experience of regulatory submissions and associated industry guidance· Familiarity with GCP and regulatory requirements· Knowledge of SDTM and ADaM CDISC standards
