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Accentuate Staffing is currently recruiting for a Clinical Data Scientist to join an established company in the RTP area.  This position will be responsible for addressing research questions using statistical methods, providing oversight of data management activities, and providing technical input to the design of research studies.

Responsibilities: 

• Prepare data and conduct exploratory analyses of clinical and research data using statistical methods.
• Be accountable for data analyses projects supported by third parties.
• Contribute to protocol development, analysis specifications, and analytical outputs for clinical studies, including pivotal registration studies.
• Provide oversight of internal data management activities and activities outsourced to vendors, including the development of clinical databases.
• Proactively address potential data issues by leading data review within Clinical Affairs throughout the conduct of a study. Assess the overall quality of data and identify trends or patterns that may pose overall study compliance and/or data quality concerns.
• Build relationships with teams in Research & Development, providing input on the design of future studies, as needed.
• Present results to stakeholders including project teams and external collaborators.
• Author Statistical Analysis Plans, internal reports, data sections of reports submitted to regulatory agencies, and manuscripts submitted to peer-reviewed journals.
• Ensure adherence to all Good Clinical Practice (GCP) global standards and department standard operating procedures for conducting clinical studies

Requirements: 

• Thorough understanding of statistical methods applied to the analysis of clinical and research data.
• Strong knowledge of core data management activities (e.g, Data Management Plans, data edit specifications, data quality assurance, database specs, electronic data transfers)
• Knowledge of and experience with clinical databases (EDC systems).
• Ability to write summary reports and technical articles for publication in professional journals
• Bachelor’s Degree in Statistics or a relevant scientific discipline with 10+ years, OR Master’s degree with 5+ years; or equivalent combination of education and experience
• Experience working in IVD development a plus.