Job Title: Principal Biostatistician
📍 Location: Bangalore
🏢 Category: Clinical
🆔 Job ID: 254114
Job Overview
Lead complex clinical studies, including NDA submissions and multi-protocol programs. Provide statistical oversight, project management, mentoring, and quality review of analyses, TFLs, and reports. Represent the department in audits and contribute to new business initiatives.
Key Responsibilities
📊 Statistical Leadership
Lead complex studies across multiple locations, providing statistical oversight.
Develop and review complex Statistical Analysis Plans (SAPs).
Perform complex statistical analyses and quality check analyses developed by other statisticians.
Conduct overall statistical review of TFLs prior to client delivery.
Develop statistical sections of protocols and provide statistical input for Clinical Study Reports (CSRs).
Prepare and review randomization specifications and generate randomization schedules.
🗂️ Project Management
Perform project management activities including resource planning, timelines, and milestone management.
Serve as DMC Support Statistician, developing DMC charters and attending DMC meetings.
Represent department during audits.
Attend bid defense meetings for complex studies to support business growth.
👥 Mentorship & Training
Mentor and train less experienced staff.
Provide direction and review work of departmental employees to ensure accuracy and adherence to policies and procedures.
Present and share knowledge in team meetings, seminars, and external conferences.
📝 Documentation & Compliance
Act as Subject Matter Expert (SME) on procedural documents or new initiatives.
Review CRFs and other study-specific specifications and plans.
Minimum Qualifications
🎓 Education:
Bachelor’s degree or equivalent experience.
Fortrea may consider relevant and equivalent experience in lieu of formal education.
💼 Experience:
8+ years of experience, or equivalent combination of education and experience.
Ability to program in one or more statistical software packages (SAS®).
SAS proficiency, including non-parametric analysis, linear/non-linear models, categorical data, and survival analysis.
Good knowledge of the overall clinical trial process.
Competence in preparation of SAPs, analyses, and reporting across a variety of trials.
🗣️ Skills & Competencies:
Proven ability to effectively communicate statistical concepts.
Preferred Qualifications
Master’s degree or higher in Biostatistics or related field.
Physical Demands / Work Environment
Office or home-based environment as requested by line manager.
Travel: ~5% of time, potentially including overnight stays for client meetings or trainings.
Equal Opportunity & Accommodation
Fortrea is an Equal Opportunity Employer committed to providing reasonable accommodations to qualified individuals.
📎 Learn more about EEO & Accommodations [here].
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