Senior/Principal Statistical Programmer - Submissions

Warman O'Brien

Newcastle upon Tyne

2 days ago

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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.

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