Principal Programmer Oncology

• 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

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