Senior Statistical Programmer

Overview Work as a senior programmer on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. Good knowledge of CDISC SDTM and ADaM implementation guidelines; producing, reviewing and updating complex data specifications; creating and debugging complex macros; understanding Statistical Analysis Plans (SAPs) and output shells for day to day programming activities. Excellent team work ethos, 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. · Program complex non efficacy outputs/ figures · Perform Senior Review and Deliver QC of non- statistical output · Develop and debug complex macros Become involved in developing the standard macro library and take responsibility to implement standard macros within a study · Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc · Review more complex study design SAP without supervision · Review all shells without supervision and provide feedback · Knowledge, interpretation and implementation of current SDTM, ADAM standards · Knowledge of FDA CRT requirements including define.xml and define.pdf · Lead team and be responsible for creation of CRT packages · Become familiar with and follow study documentat