Senior/Principal Programmer
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Job Description
Senior/Principal Programmer overseeing programming efforts for clinical and non-clinical trials. Producing complex datasets while adhering to timelines and collaborating with cross-functional teams.
Responsibilities:
- Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
- Program complex non efficacy outputs/ figures
- Develop and debug complex macros
- Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies
- Review simple 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 single study, ensuring quality and timely delivery
- Liaise with Study Statistician and Project Manager regarding resourcing and deliverables
- Responsible for study level resources
- Point of contact for programming issues for the team, proactively ensuring everything is working cohesively
- Persuade stakeholders to follow best practice within a trial
- Assist in development of internal training courses
Requirements:
- 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
- Familiarity with GCP and regulatory requirements
- Experience of programming to SDTM and ADaM standards
Benefits:
- Professional development opportunities
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