Position Title: Biostatistician (Lead Role – Simple to Medium Complexity Studies)
Department: Biostatistics
Reports To: Line Manager / Senior Biostatistician
Location: Office-based or remote (as approved by Line Manager)
Summary of Responsibilities
The Biostatistician serves as the Lead Biostatistician on simple studies, providing statistical oversight, performing analyses, and contributing to study design, planning, and reporting. This role supports the delivery of high-quality statistical outputs while ensuring adherence to timelines, budgets, and regulatory standards.
Key Responsibilities
Project Leadership and Oversight
Serve as Lead Biostatistician on simple studies, providing statistical input and oversight.
Attend and contribute to relevant project and client meetings.
Maintain awareness of project budgets, timelines, and deliverables; communicate status updates to line management and project managers as appropriate.
Statistical Planning and Analysis
Prepare Statistical Analysis Plans (SAPs), including mock Tables, Figures, and Listings (TFL) shells, for simple and medium complexity studies under supervision of senior statistical staff.
Perform statistical analyses for medium complexity studies in compliance with project and regulatory requirements.
Conduct overall statistical review of TFLs for medium complexity studies prior to client delivery.
Perform and/or assist with sample size calculations for Clinical Pharmacology studies under supervision.
Study Design and Documentation
Review Case Report Forms (CRFs) and other study-specific documentation, specifications, and plans.
Provide statistical input to and review Clinical Study Reports (CSRs) for simple studies.
Generate and review randomization schedules based on provided specifications under the guidance of senior statistical staff.
Quality and Compliance
Ensure accuracy, consistency, and adherence to statistical and regulatory standards.
Perform all duties according to company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
Contribute to continuous process improvement within the Biostatistics department.
Other Responsibilities
Perform additional tasks and responsibilities as assigned by line management or project leads.
Qualifications
Education
Master’s degree (or equivalent) or higher in Biostatistics or a related field.
Preferred: Bachelor’s degree in a related field with relevant experience.
Experience
3–5 years of relevant experience, or an equivalent combination of education and experience sufficient to perform key job responsibilities.
Demonstrated experience in applying statistical methodologies to clinical research data.
Skills and Competencies
Proficiency in one or more statistical software packages (SAS® preferred).
Strong understanding of statistical concepts and their application in clinical studies.
Excellent communication skills with the ability to explain complex statistical ideas to non-statistical audiences.
Detail-oriented with strong organizational and time management skills.
Ability to work collaboratively in cross-functional teams and independently under limited supervision.
Physical Demands and Work Environment
Work may be performed in an office or home-based setting.
Travel Requirement: Yes, as needed for project or client meetings.
Equal Employment Opportunity (EEO)
Fortrea is committed to providing equal employment opportunities and reasonable accommodations for individuals with disabilities. Learn more about our EEO & Accommodations policy [here].
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