Principal Programmer Oncology

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 a