Job Title: Principal Biostatistician
Location: Bangalore, India
Category: Clinical
Job ID: 254114
About Fortrea
Fortrea is a leading global Contract Research Organization (CRO) providing clinical development and technology solutions to pharmaceutical, biotechnology, and medical device customers worldwide. Operating in approximately 100 countries and covering more than 20 therapeutic areas, Fortrea is dedicated to transforming drug and device development for partners and patients globally.
Our culture, Fortrea FOUR, focuses on Forward Together, Own It, Uphold Integrity, and Respect People. Join us to thrive in a collaborative environment that nurtures personal growth and global impact.
Learn more at: www.fortrea.com
Job Overview
The Principal Biostatistician leads complex clinical studies, including NDA submissions and multi-protocol programs. This role involves statistical oversight, project management, mentoring, and active participation in scientific and business meetings.
Key Responsibilities
Lead complex clinical studies, coordinating activities across multiple sites and providing statistical oversight.
Manage project activities including resource planning, timelines, and milestone tracking.
Serve as Data Monitoring Committee (DMC) Support Statistician by developing DMC Charters and attending DMC meetings under direction of Statistical Consultants.
Lead the development and senior review of complex Statistical Analysis Plans (SAPs).
Perform and quality check complex statistical analyses.
Conduct comprehensive statistical review of Tables, Figures, and Listings (TFLs) prior to client delivery.
Review Case Report Forms (CRF) and study-specific plans and specifications.
Perform complex sample size calculations under supervision.
Develop statistical sections of protocols for complex studies under consultant supervision.
Provide statistical input and review Clinical Study Reports (CSRs) for complex studies.
Prepare and review randomization specifications and generate randomization schedules.
Mentor and train junior statisticians; review their work for accuracy and adherence to departmental policies.
Present knowledge at monthly seminars, team meetings, and external scientific conferences.
Participate in bid defense meetings for complex studies to secure new business.
Act as a Subject Matter Expert by developing or reviewing procedural documents and new initiatives.
Represent the department during audits.
Perform other duties as assigned.
Qualifications
Minimum Education
Bachelor’s degree (Fortrea may consider relevant and equivalent experience in lieu of formal education).
Experience
8+ years of relevant experience or equivalent combination of education and experience.
Proficient in programming statistical software packages, especially SAS®.
Experienced in using a variety of SAS statistical procedures (non-parametric analysis, linear/non-linear models, categorical data, survival analysis).
Strong understanding of clinical trial processes and applications within Fortrea Clinical Development.
Skilled in preparation of Statistical Analysis Plans, analysis, and reporting across diverse trial types.
Proven ability to communicate statistical concepts effectively.
Preferred Qualifications
Master’s degree or higher in Biostatistics or related field.
Skills and Competencies
Advanced statistical analysis and project management skills.
Strong leadership and mentoring capabilities.
Excellent verbal and written communication.
Ability to work independently and collaboratively across multiple teams and locations.
Competence in audit representation and regulatory compliance.
Work Environment and Travel
Work environment is office or home-based as per line manager’s discretion.
Travel required approximately 5% of the time, including potential overnight stays for client meetings and training sessions.
Equal Employment Opportunity & Accessibility
Fortrea is an Equal Opportunity Employer and provides reasonable accommodations to individuals with disabilities during the hiring process.
How to Apply
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