Duties: Conducts advanced scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations, including the design, development and execution of the technical/statistical infrastructure; Possesses an advanced understanding of modern drug discovery and development processes; Represents Biostatistics as a member of clinical trial teams, providing input and technical guidance to elicit meaningful and/or productive outcomes; With minimal guidance, authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) to facilitate the review, summary, and dissemination of key study data/results; Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with good quality
Requirements: Ph. D. or master's degree in Statistics or Biostatistics; Typically requires 3 years of experience with a Ph.D. or 6 years of experience with a master's degree, or the equivalent combination of education and experience