Senior Programmer II (India)

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 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.

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
· Perform Senior Review and Deliver QC of non- statistical output
· Develop and debug complex macros
· Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
· Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc
· Review more complex 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 programmer on a single study, ensuring quality and timely delivery
· Liaise with Study Statistician and Project Manager regarding resourcing and deliverables
· 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
· Persuade stakeholders to follow best practice within a trial
· Develop and deliver company-wide training as and when required
· Create, review and update processes and SOPs
· Take responsibility for study compliance with SOPs and processes

· 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