Principal/Senior- Statistical Programmer-MPD

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.

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

· 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