The Senior Statistician MS performs high-level client statistical consulting and/or leads teams within Navitas Data Sciences and at clients. The Senior Statistician primary focus is to lead and perform the statistical planning and statistical analysis of clinical studies.

• Perform Statistical Analysis in support of Phase I-V clinical trials, ISS, ISE, Registries, Publications or other related regulatory submissions
• Design data acquisition trials, assessing results and analyzing trends
• Developing and reviewing Study Protocols and Statistical Analysis Plan
• Develop Integrated Safety Summary (ISS) and Integrated Efficacy Summary (ISE) Plans
• Orchestrate the analysis specifications through data analysis
• Implement Table, Listing and Figure specifications
• Develop and implement the Analysis Data Set Specifications
• Applying statistical methodology to complex data
• Write the Statistical Section for a Clinical Study Report, ISS and ISE
• Use statistics to make forecasts and to provide projected figures
• Present information in a variety of formats
• Represent the client at regulatory agency meeting such as the FDA
• Interface with client senior management
• Develop, publish and present white papers and presentations at industry conferences
• Lead one or more studies at a client

• Excellent management, interpersonal, communication, and organizational skills
• Ability and desire to interface with senior management and executives in client engagements and industry associations
• Ability to assess, analyze, develop and present statistics-based information to clients
• Recognized industry authority by clients and industry peers
• 5 plus years Pharmaceutical or CRO industry experience
• Working knowledge of CDISC, SDTM and ADaM
• Minimum 2 years’ technical project management experience directing statisticians and statistical programmers
• Experience in developing, writing, publishing and presenting industry papers at conferences.