Principal/Senior Programmer

Job Description

Employees may be required to perform some or all of the following... Program and validate SDTMs and ADaMs, 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 Become familiar with and follow study documentation Ensure the principles in the Phastar checklist are followed rigorously Archive study documentation following instructions in supplied SOPs Act as a Lead Programmer, ensuring quality and timely delivery Liaise with the Study Statistician and Project Manager regarding resourcing and deliverables Assess and monitor 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 Qualifications Educated to BSc or above within Computer Science, Mathematics or a Science related discipline 5+ years of CDISC standards experience (i.e. programming SDTMs and ADaMs) 5+ years of SAS programming experience within the pharmaceutical/CRO industry (essential) ISS/ISE experience (essential) Excellent communication skills Good awareness of clinical trial issues, design, and implementation Familiarity with GCP and regulatory requirements