Real World Evidence Analytics Contractor

Primary Responsibilities Include:

• Provides project-based work to support the Directors and RWE leads; projects require both independent working as well as collaboration with the senior leaders in the function.
• Contributes towards the development and maintenance of an RWE data repository.
• Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned RWE projects.
• Creates automated, standard programming; SAS macros, SQL coding and stored procedures as required.
• Creates and validates tables, figures, and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements.
• Provides input in the design and development of prospective and retrospective RWE studies and work with RWE study leads to conduct studies from protocol to output generation following quality standards.
• Evaluates in-house and vendor data (claims, EMR, PRO) critically and conducts the essential quality checks to assess appropriateness of use
• Provides input in the user requirements specification, system design specifications, validation plan, and installation/operational/performance qualification for statistical programming systems.
• Provides programming support for ad hoc analysis.
• Manages project timelines and schedules of specific phases of projects with internal personnel and external vendors.
• Provides assessment, interpretation and communication of relevant scientific literature; maintains awareness of internal and external data resources; identifies appropriate studies for addressing questions of interest, independently performs data queries and summarizes epidemiologic information.
• Contributes to and reviews RWE content for study protocols, SAPs, study reports, slide decks, abstracts, posters, publications, and other presentations of scientific findings.
• Contributes to integration of RWE into the R&D clinical development process and post-marketing activities via participation in cross-functional clinical trial, clinical development, and global development teams, as well as RWE sub-teams.
• Performs other related duties as needed.

Desired Education and Skills:

• MS in biostatistics/statistics, epidemiology or computer science or a related field with at least 5 years (or BS in statistics, computer science or a related field with at least 8 years) of SAS programming experience in healthcare data analysis, pharmaceutical, or biotech industry.
• Experience using SQL and management of large data.
• Experience conducting analysis in retrospective claims data (open and closed claims) using ICD-9/10, CPT, HCPCS and NDC coding (survey data, patient-reported and clinical trial data a plus).
• Understanding and experience with implementing appropriate QC steps in handling large data including data merging.
• Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, RWE leads, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
• Experience with rare disease, and/ or muscular dystrophy is a plus.
• Demonstrated ability and experience in the analysis and reporting of real-world studies (retrospective and prospective) and patient reported outcomes.
• Experience in project management of statistical programming activities.
• Proven ability to manage CRO relationships and oversee programmed deliverables.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Excellent written and verbal communication skills and organizational and documentation skills.
• Excellent problem-solving skills.
• Ability to prioritize and multi-task effectively.
• Demonstrated positive attitude and the ability to work well with others.