Principal Biostatistician

Join to apply for the Principal Biostatistician role at InspireMD

Join to apply for the Principal Biostatistician role at InspireMD

Position Summary : The Principal Biostatistician will use statistical expertise in study design and analysis of data to support the generation of evidence for regulatory and commercial needs.

Essential Duties and Responsibilities : To perform this job successfully, an individual must be able to perform the following satisfactorily; other duties may be assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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.

Requirements : To perform the job successfully, an individual should demonstrate the following.

• 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.
• Experience with analysis of medical device trials for PMA or 510(k) preferred.
• Excellent critical thinking skills.
• Experience in product safety including serving on DSMBs preferred.
• 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.

Education / Experience

• Master’s degree in Biostatistics or Epidemiology and 8+ years of direct and related experience in medical device, pharmaceutical, biotechnology industry or PhD and 6+ years of experience.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

Seniority level

Seniority level

Associate

Employment type

Employment type

Full-time

Job function

Job function

Research

Medical Device

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Inferred from the description for this job

Medical insurance

Vision insurance

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