Biostatistician

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Biostatistician

June 2021

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 Attributes of the 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).

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.

Education and Experience Required:

  • 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.

Physical Requirements

  • May involve domestic travel as needed.

To apply, please email your cover letter, resume and salary requirements to: careers@hemosonics.com.

HemoSonics, LLC is an equal opportunity employer. All applicants will be considered for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Why HemoSonics?

HemoSonics is a growing team of scientists, engineers, regulatory and business professionals all focused on transforming the way clinicians manage coagulation dysfunctions by providing comprehensive, timely information on coagulation status at the point of care.

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