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