Senior Statistical Programmer
3 weeks ago
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
ttend 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
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