* A specialist CRO is looking to hire a Senior Programmer to join them on a permanent basis. Working across clinical and non-clinical studies, you will support regulatory submission activities;
produce and validate datasets and outputs whilst adhering to deliverable timelines.
* Excellent knowledge of CDISC SDTM and ADaM implementation guidelines is required. You will produce, review and update complex dataset specifications (including efficacy);
* create and debug complex macros;
review Statistical Analysis Plans (SAPs), including study specific ISS / ISE and DSMB SAPs and output shells with a view to commenting from a programming perspective.
This position is remote (although can be office based or hybrid, depending on your location) and will involve occasional travel to events throughout the year.
Responsibilities
* Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
* Become independent technical expert
* Program complex non-efficacy outputs / figures
* Perform Senior Review and Deliver QC of non-statistical output
* Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
* Validate and perform User Acceptance Testing (UAT) on standard macros
* Identify macros requirements, communicate and perform training
* Create, QC and update complex dataset specifications (including efficacy) for single / multiple studies, ISS / ISEs, etc.
* Implement and coordinate development and maintenance of standard specifications
* Be an SDTM and ADaM expert providing consultancy, advice and training
* Be a CRT expert providing consultancy, advice and training
* Develop archiving systems and processes
* Act as a Lead programmer on multiple studies and projects, ensuring quality and timely delivery
* 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
* Develop and deliver company-wide training as and when required
* Create, review and update processes and SOPs
Qualifications
* Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
* SAS Programming Experience within the pharmaceutical industry
* Good awareness of clinical trial design and implementation
* Experience of regulatory submissions and associated industry guidance
* Familiarity with GCP and regulatory requirements
* Knowledge of SDTM and ADaM CDISC standards
For additional information and a confidential discussion, please apply now with an updated CV.
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