Senior Biostatistician

Summary of Responsibilities: Perform Lead Biostatistician role on medium complexity studies, providing statistical oversight and attending relevant project meetings. Perform project management activities for identified projects including resource planning, timelines, and milestone management. Preparation of Statistical Analysis Plans (including mock TFL shells) for medium complexity studies under the supervision of more senior statistical staff.

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. May perform sample size calculation for simple studies under the supervision of more senior statistical staff.

Develop the statistical sections of the protocol for simple to medium complexity studies under the supervision of a statistical consultant. Provide statistical input and review of the CSR for medium complexity studies. Preparation and review of randomization specifications and generation of randomization schedules. Mentor of biostatisticians within project activities; assigned tasks related to the development of staff within the department.

Present and share knowledge at team meetings and/or at monthly seminars. Attend bid defense meetings for medium complexity studies in order to win new business. Represent the department during project-driven client audits. All other duties as needed or assigned.

Qualifications

(Minimum Required): Bachelor’s degree required. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Must have an excellent command of the English language, both oral and written. Experience (Minimum Required): 5-8 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. Ability to effectively communicate statistical concepts.

A good knowledge of the overall clinical trial process. Experience in the preparation of Statistical Analysis Plans, analysis, reporting, etc.

Preferred Qualifications

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 is primarily to Client meetings and trainings up to 5% of the time, with 100% of that time requiring an overnight stay. Learn more about our EEO & Accommodations request here .