Introduction: 

The Senior Statistical Analyst (Safety) 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 development and maintenance of integrated clinical safety data for one or more compounds/indications of lower complexity or therapeutic areas in early development. The Senior Statistical Analyst (Safety) interfaces with Statistics, Data Sciences, Clinical Analytics, Medical Writing, Regulatory Publishing and Clinical Operations.    

Responsibilities: 

• Leads the statistical programming activities of safety data integration and analysis for projects with lower complexity in creating integrated safety data sets to support safety monitoring, signal detection, clinical safety analytics and regulatory submissions.
• Leads the statistical programming activities for IB/DSUR/PSUR/ASR/RMP.
• Develop SAS programs for the creation of ADaM data sets following CDISC standards.
• Develops and oversees the development of SAS programs, Product safety data integration plan, metadata and 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.

• 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.
• Indepth 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.

.