Need a freelancer to help in executing a SAS based programming assignment.
· 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)
· 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
· Manipulating and analyzing adjudicated data
· Data preparation and analysis for Global Medical Affairs work
· Clinical Trial Transparency deliverables (data de-identification, results posting files)
· 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.
· Solid experience in the RWE space in SAS, plus R proficiency (ideally) with registry/observational study experience and exposure to RWD Data sources (EMR, claims, 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