- Serves as the lead biostatistician on programs of studies or submissions, or on simple to complex individual studies.
- Serves as an independent reporting statistician on data monitoring committees.
- Develops statistical analysis plans and reporting specifications for simple to complex clinical studies.
- Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies.
- Performs senior review of TFLs and statistical analysis plans.
- Provides significant input in the development and review of CRFs, edit specifications, and critical variable lists.
- Performs lead review of TFLs and derived datasets for clinical studies.
- Contributes to clinical study protocols and clinical study reports.
- Reviews simple to complex randomization specifications and dummy randomization schemes.
- Trains and mentors new or junior statisticians on statistical methods and PRA procedures.
- Provides statistical training at monthly seminars.
- Participates in bid defense meetings.
Master’s degree in statistics or biostatistics required.
Minimum of 8 years of biostatistical experience desired.
Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures, and good programming practices.
Demonstrates ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical trials.
Displays excellent communication skills with demonstrated leadership ability.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities.