Senior / Principal Statistical Programmer - Submissions

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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