Senior Statistical Programmer

vor 1 Woche

Berlin, Deutschland PHASTAR Vollzeit

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 documentation - Lead a team for furthering programming development - Ensure the principles in the PHASTAR checklist are followed rigorously - Archive study documentation following instructions in supplied SOPs - Act as a Lead programmer on multiple studies under same 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 - 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 - SAS Programming Experience within the pharmaceutical industry - Good awareness of clinical trial issues, design, and implementation. - Familiarity with GCP and regulatory requirements - Experience of programming to SDTM and ADaM standards"

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