/Senior) Biostatistician, RWE (12)

Lead 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 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.