Category

Description

• Develops statistical analysis programs to merge complex data structures from multiple databases, create analysis data set (ADS) and generate tables, listings, and figures (TLF) for reports.
• Evaluate protocol designs for SSI outcomes study
• Participate in development of database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations. Ensures data specifications align with statistical analysis requirements and goals.
• Will run multiple statistical analyses based on multiple assumption sets that will include the type of surgery, expected rates of infection, non-inferiority vs “same as” or “no different than” and various confidence intervals
• Contributes to the development of processes, procedures, and standards associated with analysis of clinical studies, data management, and reporting for regulatory submissions.
• Keeps abreast of new developments in statistics, industry development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
• Provide an understanding of how many patients/procedures will be needed to achieve statistical significance.

• Minimum educational background of MS in statistics/biostatistics or other quantitative field.
• 8+ years of experience, preferably in medical device or pharmaceutical industries.
• Proficiency in statistical programming (SAS, R) and query of relational database systems (SQL). Certifications in SAS programming a plus.
• Experience with extraction of data and reporting within Clinical Data Management systems
• Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, sample size calculations.
• Familiarity with surgical site infections (SSI) is a plus
• Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solution to novel problems.
• Familiar with FDA guidelines and other regulatory requirements is a plus.
• Experience with analysis of complex data from multiple source.
• Ability to work independently and in project teams.
• Excellent communication skills (written and spoken). Strong ability to interact with others and to distill complex concepts in simpler terms to generalized audiences

Get In Touch