Principal Biostatistican
Job Description
Summary of Responsibilities:
- Lead complex studies such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight, and attending relevant project meetings.
- Perform project management activities for identified projects including resource planning, timelines, and milestone management.
- Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical Consultants.
- Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians.
- Perform complex statistical analyses, quality check statistical analyses developed by other statisticians.
- Conduct overall statistical review of TFLs for complex studies prior to client delivery.
- Review CRF and other study specific specifications and plans.
- Perform complex sample size calculations under the supervision of more senior statistical staff.
- Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant.
- Provide statistic input and review of the CSR for complex studies.
- Preparation and review of randomization specifications and generation of randomization schedules.
- Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures.
- Present and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferences.
- Attend bid defense meetings for complex studies such as NDA submissions or complex, multiprotocol programs in order to win new business.
- Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives.
- Represent the department during audits.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- Bachelor’s degree.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required):
- 8+ years of experience or an equivalent combination of education or experience to successfully perform the key responsibilities of the job.
- Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses.
- SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data, and survival analysis.
- Proven ability to effectively communicate statistical concepts.
- A good knowledge of the overall clinical trial process and of its application within Fortrea Clinical Development.
- Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials.
Preferred Qualifications Include:
- Master’s degree, equivalent, or higher in Biostatistics or related field.
Physical Demands/Work Environment:
- Office or home-based environment, as requested by the line manager.
- Travel Requirements: % of time: Approximately 5%. % of the above that requires overnight stay: Approximately up to 100%. Travel is primarily to where: Client meetings and trainings.
Learn more about our EEO & Accommodations request here.