Sr. Statistical Analyst

Job Description • The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products. • The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for clinical studies and projects with lower complexity. • The Senior Statistical Analyst interfaces with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations. Responsibilities: • Leads the statistical programming activities for projects with lower complexity. • Leads the statistical programming activities for studies. • Develop SAS programs for the creation of ADaM data sets following CDISC standards. • Develop SAS programs for the creation of Tables, Listings and Figures. • Validation of ADaM data sets, Tables, Listings and Figures. • Create specifications for the structure of ADaM data sets for individual studies and integrated data. • Create documentation for regulatory filings including reviewers guides and data definition documents • Leads the development of standard SAS Macros and participates in the development of standard operating procedures. • Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts. Requirements: • MS in Statistics, Computer Science or a related field with 6+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 8+ years of relevant experience. • In-depth understanding of SAS programming concepts and techniques related to drug development. • Fundamental understanding of CDISC Standards. • Fundamental understanding of the drug development process, including experience with regulatory filings. • Ability to communicate clearly both oral and written. • Ability to accurately estimate effort required for study related programming activities.