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.
CLIENT REQUIREMENTS:
SDTM Mapping and specs experience is a must.
CDISC knowledge is a must.
CLinical Trial Expereince is a must.
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· 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 on a set of deliverables within a study eg: all SDTMs, all Tables etc.· 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
Qualifications
· Bachelors 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
