SAS Programmer (RWE)

Need a freelancer to help in executing a SAS based programming assignment.

Typical Accountabilities:

· 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.

Qualifications:

· 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

SAS Programmeringssproget R Programmering af database

Projekt ID: #31541929

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