Principal Biostatistician – Clinical Development | Novartis, Hyderabad
Job Summary:
Novartis is seeking a Principal Biostatistician to provide statistical leadership and expertise across global clinical trials and development programs. This role supports full lifecycle statistical analysis, regulatory submission planning, and implementation of high-quality data standards. You’ll influence key decision-making in drug development and be part of a high-impact, cross-functional team driving innovation in biostatistics and clinical research.
Key Responsibilities:
Lead statistical tasks across mid- to high-complexity trials, including protocol and statistical analysis plan (SAP) development.
Support regulatory submissions with robust statistical analyses and documentation.
Design exploratory, pharmacokinetic (PK/PD), and biomarker analyses aligned with development goals.
Propose and implement innovative clinical trial designs and Bayesian methodologies.
Ensure timely and high-quality biostatistics deliverables across study phases.
Represent Novartis at regulatory meetings, external conferences, and scientific forums.
Collaborate cross-functionally with clinical, regulatory, data management, programming, and medical writing teams.
Provide mentorship and project-level biostatistical leadership.
Required Skills & Qualifications:
PhD in Statistics (or equivalent) with 3+ years of experience, or MS in Statistics with 7+ years of relevant work experience.
Proficiency in SAS, R, and other statistical software tools.
In-depth understanding of CDISC standards, clinical trial design, and regulatory guidelines.
Experience with PK/PD modeling, Bayesian statistics, and exploratory biomarker analyses is a plus.
Strong communication, presentation, and cross-functional collaboration skills.
Proven ability to influence decisions, manage biostatistics deliverables, and support Health Authority interactions.
Perks & Benefits:
Competitive salary (not explicitly stated).
Access to Novartis Life Handbook of employee benefits.
Career development in a global pharma environment.
Inclusive culture that promotes collaboration and innovation.
Opportunities to work on groundbreaking clinical programs.
About Novartis:
Novartis Healthcare Pvt. Ltd. is a global pharmaceutical leader with a mission to reimagine medicine and improve patients’ lives through innovation. With a strong presence in India and globally, Novartis focuses on breakthrough science and transformative healthcare solutions.
Work Mode: On-site (Hyderabad, India)
Ready to Advance Global Drug Development?
Join Novartis as a Principal Biostatistician and drive scientific excellence in clinical trials.
Apply now and be part of our mission to improve and extend lives.
Visit: https://www.novartis.com/careers
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