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 implementation guidelines; working with innovative automation tools and producing, reviewing and updating complex data specifications; creating and debugging complex macros; understanding Statistical Analysis Plans (SAPs). 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.
· Working as part of SDTM automation team to ensure highest quality output to CDISC standards
· Work on a variety of different indications with the flexibility to support multiple ongoing studies when required
· Work to the most recent CDISC standards and help develop Operation tools for programming teams
· Opportunities to present at external conference of participation and experience with automation work and industry developments
· Program complex outputs via automation
· Develop and debug complex macros· Create, 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 standards
Knowledge, interpretation and implementation of current ADAM standards for Table outputs· 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· SDTM lead support for 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 SDTM/CDISC Lead on a set of deliverables within a study eg: all SDTMs, all Tables. · Liaise with Lead Coordinator, Study Team 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
