About this role
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 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 is primarily to Client meetings and trainings up to 5% of the time, with 100% of that time requiring an overnight stay.
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