Biostatistician

HemoSonics

HemoSonics, LLC is seeking an experienced Biostatistician to provide statistical support for clinical studies conducted by and for HemoSonics, and to provide statistical consultation to R&D and manufacturing teams. This includes providing input to clinical development plans, writing statistical analysis plans and statistical sections of clinical and research protocols, contributing to reports/abstracts/publications, and analyzing data for clinical and research studies.

Key Responsibilities

  • Provide input on study protocols, develop data analysis and statistical analysis plans, and write data analysis sections of protocols.
  • Be accountable for selecting appropriate statistical methods for data analysis.
  • Generates sample size calculations appropriate for the primary endpoint and based on input from the protocol.
  • Develop mock-up of tables, listing, and figures from the Statistical Analysis Plan.
  • Analyze study data using statistical methods per statistical analysis plan and prepare summarized report.
  • Conduct exploratory analyses of clinical and research data as needed.
  • Be accountable for data analyses projects supported by third parties.
  • Participate in regulatory meetings to answer/defend statistical related quires.
  • Build relationships with teams in Research & Development, providing input on the design of nonclinical research studies, as needed.
  • Provide statistical consultation to R&D and manufacturing teams
  • Work with CRA during (e)CRF development to ensure adequacy of data collection with respect to statistical endpoints derivability.
  • Present results to stakeholders including project teams and external collaborators.
  • Author 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 handling clinical data.

Experience and Qualifications

Key Attributes of Successful Candidate:

  • Thorough understanding of statistical methods applied to the analysis of clinical and research data.
  • Knowledge and experience with clinical databases.
  • 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.).
  • Experience working with clinical databases (EDC systems).

Education & Experience Requirements:

  • Master’s degree in Statistics or a relevant scientific discipline with 5+ years; OR PhD in health sciences field with 1+ year; OR Bachelor’s Degree in Statistics or a relevant scientific discipline with 10+ years.
  • Experience working in IVD development a plus.
  • May involve domestic travel as needed.

Sectors

  • Other
  • Clinical Research

Job Type

Full-time

Address

Charlottesville, Va.
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