Experienced RWA Analyst/Programmer
- Experience Level
- Experienced (non-manager)
- The RWA programmer has to have knowledge and experience of working with RWE (EHRs, Claims/Payer data etc) and be able to employ newly evolving methodologies as well as current practice. The RWA group has a wide remit of evidence framing, knowledge of data assets, registries, pragmatic trials, external control arms that experience in one of these areas would be of benefit.
- Delivers the programming aspects of RWA from development of analytical datasets, analysis of efficacy and safety endpoints plus exploratory analysis
- As a member of RWA Analytical team, they will collaborate with the Programming Leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project, including but not limited to the following:
- Data submission strategy (e.g., managing legacy data, pooling data)
- Responses to regulatory agency queries
- Tables Figures and Listings (TFLs)
- Development Safety Update Reports (DSURs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Investigators brochures (IBs)
- Office of Scientific Investigations (OSI) data sets and listings
- Regulatory and/or Payer submission related analysis data sets and/or TFLs
- Associated quality and process documentation as per applicable business processes
- Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets
- Pharmacokinetics/pharmacodynamics data preparation and analysis
- Manipulating and analyzing adjudicated data
- Data preparation and analysis for Global Medical Affairs work
- Clinical Trial Transparency deliverables (data de-identification, results posting files)
- Timely upload of documents to eTMF
- Produce and maintain the technical database standards and Programming Specification documents.
- Contributes to and/or lead aspects of the provision of technical consulting expertise to external partners in relation to the specifications and delivery of the appropriate data model databases (eg. OMOP, SDTM )by these partners.
- Contributes to and/or lead the development of best practice to improve quality, efficiency and effectiveness.
- Identify opportunities to improve the methodology and provide practical solutions for problems.
- Lead the quality of own programming work as well as the completeness of applicable quality and process documentation.
- Accountable for good Information Practice on all assigned activities.
- When deployed to a drug project team, operates under the leadership, direction and oversight of a Global Product Programmer (GPP) or her/his delegate.
Education, Qualifications, Skills and Experience
- BSc in mathematics, statistics, engineering, computer science, or life or social sciences.
- Advanced Statistical programming knowledge and experience eg SAS , R etc .
- Knowledge of database set-up and report publishing requirements.
- Advanced knowledge of technical and regulatory requirements related to the role.
- Knowledge of RWA Data models and industry best practices.
- Advanced knowledge and experience of clinical drug development or healthcare and RWA
- Develop and deliver training.
- Able to demonstrate team working and role leadership skills appropriate to level.
- Advanced verbal, written, communication and collaboration skills.
- Advanced problem solving and conflict resolution.
- Helps drive others to work across global & functional boundaries.
- Travel – willingness and ability to travel domestically and/or internationally.
- Ability to apply programming knowledge and skills to problems and quality focus. Troubleshoots for team.
- Contributes to defining business processes and accurately completes and manages associated documentation.
- Team commitment: prioritize attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team.
- Diligence – attention to detail and ability to manage concurrent projects and activities within those projects.
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