Senior Statistician

Navitas Life Sciences -
Remote

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Job Details

Full-time

Qualifications

FDA submissions
Statistics
Report writing
Statistics
Predictive modeling analysis
Biostatistics-based research
Medical statistical report preparation
Conference papers
Presentations for conferences or internal meetings
Managing data teams
Research project design
Master's degree
White papers
Presentation skills
Statistics research
Pharmaceutical company experience
Clinical program data analysis
CDISC standards
Managing clinical research teams
Forecasting
Master’s degree in statistics
Participating in conferences
Communication with regulatory authorities for clinical trials
Technical project management
Senior level
Clinical data analysis
Clinical trial support in drug product development
2 years
Communication skills
General management

Full Job Description

Job Description

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.

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.

US - Remote

Masters in Statistics

Senior Statistician – Master Level

Data Sciences

Full Time

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