Job DescriptionThe 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.
About the Role- 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
Desirable Skills and Experience - 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.
