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Clinical Data Scientist

Charlottesville, VARandstad LifeSciences


Chat with me now! - https://flashrecruit.com/jobs/301172
 

Job Title:  Clinical Scientist

Job Summary

  • The Clinical Data Scientist 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.

  • 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

  • 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

  • Self-sufficient and able to work with minimal oversight

  • Detail-oriented and excellent problem-solving skills

  • Excellent verbal/written communication/interpersonal skills

  • Ability to prioritize and manage multiple tasks simultaneously

  • Proficiency with statistical platforms (SAS, R, etc)

Education & Qualifications 

  • 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.

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

 


Chat with me now! - https://flashrecruit.com/jobs/301172