Principal Biostatistician Position Description
- Designs, plans, and executes biostatistical components of clinical trials. Uses sound statistical methodology to conduct studies, prepares the statistical components of protocols, and is responsible for the statistical components of reports.
- 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 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.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.