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.