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.
- 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.
- Clinical Research