Address
Form of work Responsibilities:
- 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
- Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc.
- Knowledge, interpretation and implementation of current SDTM, ADAM standards
- Knowledge of FDA CRT requirements including define.xml and define.pdf
- Become familiar with and follow study documentation
- Lead a team for furthering programming development
- 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
- Develop and deliver company-wide training as and when required
- Experience of programming to SDTM and ADaM standards (CDISC)
Requirements:
- BSc or above in Computer Science, Mathematics or a Science related discipline
- SAS Programming experience within a clinical trials environment (CRO, pharma or academia)
- Good awareness of clinical trial issues, design, and implementation
- Familiarity with GCP and regulatory requirements
- Excellent written and verbal communication skills
