Thermo Fisher Scientific Hiring: Principal Biostatistician
Thermo Fisher Scientific is hiring an experienced Principal Biostatistician to support global clinical research programs. This role offers the opportunity to lead statistical strategy for complex clinical trials, collaborate with cross-functional teams, interact with sponsors and regulatory agencies, and contribute to high-impact drug development projects.
As a Principal Biostatistician, you will serve as a project lead or lead statistician, providing scientific leadership across multiple clinical studies while ensuring high-quality statistical analysis and regulatory compliance.
Position
Principal Biostatistician
Work Schedule
Second Shift (Afternoons)
Work Environment
Office-Based
Key Responsibilities
Lead statistical activities for multiple complex clinical trials and regulatory projects.
Serve as the lead statistician and primary statistical contact for sponsors and regulatory agencies.
Review study protocols, clinical trial designs, sample size calculations, and randomization plans.
Develop, review, and oversee Statistical Analysis Plans (SAPs).
Supervise statistical programming activities and ensure data quality for analysis.
Review efficacy and safety analyses and contribute to Integrated Clinical Study Reports.
Prepare statistical reports, manuscripts, and regulatory submission documents.
Monitor project budgets, timelines, and scope while coordinating with cross-functional teams.
Mentor junior statisticians and provide technical guidance on advanced statistical methodologies.
Support proposal development, bid defense meetings, and business development activities.
Identify opportunities to improve statistical processes and programming efficiency.
Education & Experience
Master's degree in Statistics, Biostatistics, Mathematics, or a related field (preferred).
Minimum 6+ years of relevant experience in Biostatistics or Clinical Statistics.
Experience leading statistical activities for complex clinical trials and regulatory submissions.
Required Skills
Advanced SAS® programming skills (BASE, STAT, MACRO, and GRAPH).
Strong knowledge of clinical trial design, statistical methodologies, and regulatory requirements.
Experience preparing Statistical Analysis Plans (SAPs) and Clinical Study Reports (CSRs).
Strong project management and organizational skills.
Excellent analytical and problem-solving abilities.
Effective written and verbal communication skills.
Ability to mentor team members and collaborate with multidisciplinary teams.
Strong understanding of statistical interpretation for complex clinical data.
Ability to manage multiple projects while meeting strict timelines.
Salary Package
Estimated CTC: ₹35–60 LPA (Not officially disclosed by the company. Estimated based on similar Principal Biostatistician roles, experience, location, and interview performance.)
Why Join Thermo Fisher Scientific?
Work with one of the world's leading life sciences and clinical research organizations.
Lead statistical strategy for global clinical development programs.
Collaborate with international pharmaceutical and biotechnology companies.
Gain exposure to complex clinical trials and global regulatory submissions.
Access continuous learning, professional development, and career growth opportunities.
Be part of an innovative and collaborative scientific environment.
How to Apply
Interested candidates can apply through the official Thermo Fisher Scientific Careers portal by searching for the Principal Biostatistician position and submitting their updated application online.
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