Vinodh Nallasamy
Principal Rwe Research Analyst @Novartis
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WORK HISTORY
Principal Rwe Research Analyst @Novartis
Hyderabad, IN
Lead the end-to-end design to execution and delivery of non-interventional and Real-World Evidence (RWE) studies as per Integrated Evidence Plan across multiple therapeutic areas with key contribution in Immunology.• Collaborate cross-functionally with global evidence generation, medical, biostatistics, Scientific communications and market access teams todefine evidence strategies, protocol designs, analytical methodologies, and dissemination planning.• Develop and review study concepts, protocol, statistical analysis plans (SAPs), documents on data quality and management, abstracts, and manuscripts ensuring scientific rigor and industry standards.• Provide scientific oversight for multi-country non-interventional studies, maintaining high standards of data integrity and methodological robustness.• Oversee and review vendor-developed documents and activities to ensure compliance with standard operating procedures and meet timelines.• Provide statistical expertise and methodological support to internal RWE teams and cross-functional partners.• Serve as a reviewer in internal RWE review forums, mentoring RWE Intern and analysts on best practices in programming, sample size estimation, data quality, data management, and study execution.• Identify process gaps and opportunities for continuous improvement; drive automation and innovation initiatives, acting as a super user to share learnings and best practices.• Lead multi-country collaborations during business owner time-off to maintain projects and program continuity.• Co-author methodological and implementation science studies, contributing to peer-reviewed publications and global scientific conferences.• Actively engage in industry conferences and professional forums to showcase innovative RWE methodologies and promote advancements in statistical methods including not limited to Bayesian modeling, survival analysis, and propensity score matching.
EDUCATION
Bharathiar University
M.Sc, Statistics
Bharathiar University
Master of Philosophy - MPhil, Statistics
Bharathiar University
B.Sc.,, Statistics
Bharathiar University
PG Diploma, Actuarial Science
Sri Gopal Naidu higher Secondary School
Higher Secondary (+2), Mathematics, Biology
ABOUT VINODH NALLASAMY
I am a Principal RWE Research Analyst and biostatistics leader with a strong track record of shaping evidence strategies, executing complex real-world studies, and driving methodological excellence across global healthcare programs. With advanced training in statistics and more than a decade of applied experience in observational research, oncology, immunology, and implementation science, I bring a unique combination of scientific rigor, analytical depth, and strategic leadership to every project I lead.In my current role at Novartis, I lead statistical activities for large-scale observational and clinical studies, supporting end-to-end evidence generation from study design through reporting. I collaborate extensively with cross-functional partners—including medical, epidemiology, HEOR, biostatistics, scientific communications, and market access teams—to align analytical approaches with broader evidence strategies and organizational objectives. My responsibilities span protocol and SAP development, data modeling, advanced statistical analysis, and methodological consulting, ensuring that every deliverable reflects scientific rigor and real-world relevance. I also oversee and mentor analysts and junior team members, fostering a culture of excellence, automation, and continuous learning within the RWE analytics ecosystem.A key dimension of my work includes providing expert leadership in Bayesian modeling, survival analysis, propensity score methods, and other advanced analytical techniques essential for robust real-world evidence. My experience spans EHR, claims, registry, PRO, and multi-country non-interventional data sources. I work closely with vendors to ensure CDISC-aligned outputs and efficient, high-quality study delivery, while also identifying opportunities for process improvement, automation, and innovation across the analytics workflow. My contributions extend to peer-reviewed publications, global conference presentations, and methodological research that pushes the boundaries of real-world study design and analysis.
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