Senior Principal Biostatistician | Hyderabad, India
Location: Hyderabad (Office), India
Job ID: REQ-10056839
Employment Type: Full-time | Regular
Division: Development
Business Unit: Innovative Medicines
Salary:
Estimated Range: ₹45 – ₹65 LPA
(Based on experience level, advanced statistical responsibilities, project leadership, and subject matter expertise.)
Role Summary:
As a Senior Principal Biostatistician at Novartis, you will lead high-impact clinical trial statistical strategies, contribute to global drug development programs, and implement modern trial designs and analysis methodologies. You’ll ensure scientific integrity in data interpretation, regulatory documentation, and cross-functional decision-making. This role involves both technical leadership and collaboration across global teams to shape the future of biostatistical excellence in clinical development.
Key Responsibilities:
Clinical Study Level:
Independently handle all statistical tasks for mid-to-high complexity clinical trials.
Lead protocol development, statistical analysis plans (SAPs), exploratory analyses, PK/PD modeling, and biomarker studies.
Implement innovative Bayesian statistics, adaptive trial designs, and new analysis methodologies.
Represent Biostatistics in clinical trial teams, ethics committees, and regulatory meetings.
Translate statistical findings into actionable insights for cross-functional stakeholders.
Project & Functional Leadership:
Collaborate with clinical, regulatory, medical writing, and data science teams to deliver high-quality, timely trial results.
Participate in early clinical development plans for low-complexity programs with minimal supervision.
Act as a statistical representative at internal and external health authority (HA) meetings.
Guide planning and tracking of biostatistics activities, and maintain vendor partnerships.
Organizational Impact:
Contribute to global initiatives within the line function or franchise.
Help review and implement HA statistical guidance across programs.
Participate in internal process improvements, scientific consulting, and innovation initiatives.
Represent Novartis at external conferences, peer-reviewed journals, and congresses.
Role Requirements:
PhD in Statistics (or equivalent) with 5+ years of experience
OR
MS in Statistics (or equivalent) with 7+ years of experience
Strong command of statistical concepts in clinical trials, pharmacokinetics, exposure-response modeling, and diagnostics
Proficiency in SAS, R, and data standardization tools
Demonstrated ability to work across cross-functional teams and regulatory environments
Excellent communication and project management skills, including simplifying statistical content for non-experts
Sound knowledge of CDISC, FDA, EMA, and ICH guidelines
Preferred Competencies:
Expertise in Bayesian modeling, biomarker analytics, and real-world data exploration
Experience in regulatory submissions, safety and efficacy summary reporting
Strong matrix leadership skills with experience in Franchise/Therapeutic Area strategy alignment
Strong scientific mindset with a track record of external presentations, publications, and consulting contributions
Why Join Novartis?
At Novartis, we’re transforming medicine and patient outcomes with science, data, and collaboration. You’ll be part of a passionate community that thrives on innovation and inclusion.
🔗 Explore Novartis Culture & Strategy
📘 Read Our Novartis Life Handbook – Benefits & Rewards
Join the Talent Network:
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