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
Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.
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