Principal Biostatistician

ACCOUNTABILITIES:
1. Develops, modifies, and/or implements statistical techniques and processes for the analysis of clinical study data.
· Consults with and advises other statisticians and our clients on statistical methodology, study design, and data analysis.
· Works with functional and project managers to determine resource projections and project schedules.
· Develops innovative statistical strategies in complex new areas.
· Provides significant input into the design, preparation, and review of clinical study protocols and consults in the development of case report forms (CRFs).

2. Develops, provides guidance on, and prepares statistical analysis plans and reporting specifications; performs statistical analyses and interprets results.
· Writes and reviews statistical sections for clinical study protocols.
· Writes statistical analysis plans for complex studies.
· Coordinates data summarization and analysis with statistical programmers, writers, and clinicians.
· Contributes to and reviews clinical study reports including summary statistics, graphics, tabulations, and raw data listings for
· Reviews work of other biostatisticians.

3. Provides leadership on statistical issues to clinical study project teams.
· Serves as primary functional representative on programs of studies, on submissions, or on numerous individual studies.
· Serves as an unblinded Statistician on Data Monitoring Committees.
· Interacts with project teams and clients including preparation of bid proposals and marketing presentations, statistical consulting, and representing clients regarding statistical issues at regulatory meetings.
· Provides leads for new Business Development opportunities.
· Visits clients to provide consultancy on statistical issues.
· Provides formal classroom as well as in-service training as requested by the functional manager.
· May assume role of project manager.

4. Mentors all levels of Biostatistics personnel.

Qualifications

· MS and/or PhD degree in Statistics or Biostatistics
· Demonstrated expertise in multiple statistical areas
· Substantial statistical experience in a pharmaceutical industry-related environment is required
· Demonstrated ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical trials
· Excellent communication skills with demonstrated leadership ability
To find out more about Real please visit www.realstaffing.com