Senior Programmer II - CNS

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 multiple studies under same project, 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

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

Experience with eCOA is a plus.
Collect experience in PRO or outcomes data, if applicable.