Overview

Duties / Expectations of Role

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.
Requirements

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.

Tagged as: biostatistician, Consultant, pharmaceutical