SAS Programmer (Risk Based Quality Management)

SAS Programmer (Risk Based Quality Management)

Ashley Clarke @ RBW consulting is currently recruiting for a Senior or Principal SAS Programmer on a permanent basis working remotely. Candidates will need to have experience of risk based quality management (RBQM) and sound knowledge of clinical operations and Data Management activities. The role can be based in UK or mainland Europe.

The successful candidate will join an award winning company, listed in the Forbes 2020 for worlds best employers. They employ the best minds to help push the boundaries of human and data science.

 Due to continuing growth, I am seeking additional innovative minds to join my clients biostatistics department to help shape the future.

You will be given access to cutting-edge in-house technology, allowing you to work on global projects across a variety of therapeutic areas. You will be able to progress your career in the direction you choose to go and will encourage and mentor you along the way.

Responsibilities:

• Perform peer reviews of study setup in RBQM software, as required
• Implement the tailored Key Risk Indicators (KRIs) and Quality Tolerance Limit parameters (QTLs) specifications for each study in the RBQM system, ensuring consistency with applicable standards, in collaboration with the CDRA/RBQM+ LEAD
• Provide programming support to deliver timely and high-quality risk-based monitoring data analytics for the cross-functional study team; partner with the CDRA and RBQM+ LEAD to identify and resolve issues  as required
• Support CDRA/RBQM+ LEAD during risk review sessions with cross-functional study team throughout clinical trials lifecycle
• Support CDRA/RBQM+ LEAD in conducting end of trial summarization of risk management activities, including QTL and other issue findings summaries, in preparation for inclusion to clinical study report.
• Provide support to ensure inspection readiness for clinical risk management and clinical data risk analysis scope of activities
• Champion programming component of RBQM within the company and participates in continuous improvement and development of risk management processes and system
• Perform all programming related activities in the set up and maintenance of the Risk-Based Quality Management (RBQM) system based on study team requirements, data sources and structure, in collaboration with the Clinical Data Risk Analyst (CDRA).  This will include transforming data in SAS to for use by the RBQM system and developing and maintaining RBQM system dashboards and robust data analyses. 

Requirements:

• Proven experience in a pharmaceutical/biologics/biotechnology company
• BS/BA preferably in a scientific or technical discipline
• Experience with data analytics and data visualization technologies
• Familiarity / knowledge of clinical trials risk management concepts and principles in the Pharma or CRO industry
• High degree of accuracy and attention to detail
• Experience and understanding of clinical trial data from various sources (e.g. Clinical devices, SDTM, RAVE, IRT, CTMS, etc.)
• Knowledge of clinical trials and strong technical experience in using SAS including SAS Macros to report the results of clinical trials and/or integrated analysis for submission

To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.