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SRG Clinical
,
Gloucester, Gloucestershire
Senior Statistical Programmer
Overview
Alongside the Programming Lead you will provide support within the clinical development process, including clinical development plans, regulatory submissions, commercialisation and scientific utilisation data for the business' products. Provide programming support to deliver technical programming and information components of a project, including but not limited to: Regulatory response to agency questions Development Safety Update Reports (DSUR) Periodic Benefit-Risk Evaluation Report (PBRER) Investigators brochures (IB) Outcomes studies Pharmacokinetics/pharmacodynamics data preparation and analysis Manipulating and analysing adjudicated data Delivering Clinical Trial Transparency (data de- identification) Data preparation and analysis for Global Medical Affairs work Create and maintain the technical database standards and Programming Specification documents Contribute to the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM and RDB databases Provide support to the regulatory submissions including specification and delivery of overview databases, outputs and response to regulatory questions. Recognise opportunities to improve the methodology and provide practical solutions for problems Contribute to the development of best practice to improve quality, efficiency and effectiveness Skill required: Extensive experience programming with SAS. Knowledge of database set-up and report publishing requirements Knowledge of technical and regulatory requirements related to the role Knowledge of CDSIC standard and industry best practices Experience in clinical drug development or healthcare. Please either apply directly on here or contact me directly on either of the following: 02039 095 137 This job was originally posted as www.totaljobs.com/job/89874902