Senior/Principal Statistical Programmer - Submissions

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 an CRT expert providing consultancy, advice and training
• Develop archiving systems and processes
• Act as a Lead programmer on multiple studies and project, 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.