InspireMD · 1 month ago
Principal Biostatistician
United States
Full-time
Remote
Senior Level, Lead/Staff
6+ years expInspireMD is seeking a Principal Biostatistician who will utilize statistical expertise in study design and data analysis to support regulatory and commercial needs. The role involves developing statistical analysis plans, participating in global study designs, and leading statistical programming efforts for regulatory submissions.
BiopharmaBiotechnologyHealth CareMedical Device
Responsibilities
Development of Statistical Analysis Plans including statistical methodology, definition of derived variables, data-handling rules, mockups and ultimately analysis of study data in support of business needs
Participate in the design and execution of global studies for regulatory submissions, reimbursement, and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management
Statistical programming of deliverables for regulatory submissions, including specification and delivery of integrated databases, outputs, and response to regulatory questions
Lead analysis for publications or podium presentations
Develop SAS macros, templates and utilities for data reporting and visualization
Write and validate SAS programs to generate tables, listings, and figures (TLFs) for clinical study reports and analysis of datasets
Proactively seek out and follow best practices in programming documentation
Lead the statistical programming thinking, analysis, and reporting to relevant groups in product and study teams
Regularly communicates study status to senior management and represents the organization to key customers
Other duties as assigned
Qualification
Required
Master's degree in Biostatistics or Epidemiology and 8+ years of direct and related experience in medical device, pharmaceutical, biotechnology or PhD and 6+ years of experience
Working Knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials
Proficiency in SAS and SAS macros that includes the fuse of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data and survival analysis required
Excellent critical thinking skills
Ability to perform and interpret subgroup analyses
Ability to work effectively on cross-functional teams
Experience with Statistical modeling: Kaplan-Meier, Bayesian analysis
Effective communication skills with all levels of management
Can operate within a team and independently, with adaptability to changing requirements
Preferred
Experience with analysis of medical device trials for PMA or 510(k)
Experience in product safety including serving on DSMBs
Company
InspireMD
InspireMD is a medical device company focusing on the development and commercialization of its proprietary stent system technology, MGuard.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$282.13M2025-07-31Post Ipo Equity· $58M
2024-07-01Post Ipo Equity· $16.9M
2023-05-15Post Ipo Equity· $113.6M
Leadership Team
Marvin Slosman
Chief Executive Officer
Pete Ligotti
Executive Vice President & General Manager
Recent News
2025-11-21
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