Associate Director – Biostatistics | Hyderabad, India
Location: Hyderabad (Office), India
Job ID: REQ-10052506
Employment Type: Full-time | Regular
Division: Development
Business Unit: Innovative Medicines
Salary:
Estimated Range: ₹50 – ₹70 LPA
(Based on experience, leadership responsibilities, and statistical expertise in clinical drug development. Final offer depends on qualifications and internal equity.)
Role Summary:
As the Associate Director of Biostatistics, you will lead the strategic statistical planning, data analysis, and regulatory support across complex clinical development programs. You will serve as a statistical expert and functional leader, applying cutting-edge methods to optimize trial design, data standards, and drug development decision-making. You will also drive innovation and mentor junior statisticians across global initiatives.
Key Responsibilities:
Study & Project Level Leadership:
Lead all statistical activities for assigned high-complexity trials—from protocol design to final reporting.
Collaborate on exploratory, PK/PD, biomarker, pricing, reimbursement, and publication-related statistical analyses.
Actively participate in cross-functional clinical teams and represent Biostatistics in internal and external stakeholder interactions.
Serve as the Biostatistics lead for multiple development programs, ensuring regulatory compliance and high-quality deliverables.
Drive innovative trial designs and dose-finding strategies; influence regulatory submissions and HA meetings.
Technical Expertise & Standards:
Provide expert consultation on clinical data standards, CDISC compliance, data transfer specs, and automation systems.
Independently lead special projects involving novel statistical tools, infrastructure upgrades, and data automation.
Ensure best practices and high-quality documentation for statistical deliverables and programming specifications.
Functional & Organizational Impact:
Actively contribute to strategic planning for therapeutic area (TA) development.
Collaborate with cross-functional stakeholders—clinical, regulatory, medical writing, programming, QA, etc.—to enable quantitative decision-making.
Represent Novartis at conferences, boards, and professional forums to promote the use of innovative statistical methods.
Qualifications:
PhD in Statistics (or equivalent) with 6+ years of experience
OR
MS in Statistics (or equivalent) with 10+ years of experience
Strong background in clinical development, statistical modeling, and regulatory strategy
Proven experience in SAS, R, and statistical techniques for clinical data
Track record of leading cross-functional teams and project planning
Excellent communication skills to simplify complex statistical concepts for non-statisticians
Deep understanding of HA guidelines, CDISC standards, and regulatory documentation
Preferred Skills:
Exposure to Bayesian statistics, real-world data (RWD), biomarkers, PK/PD, or diagnostics analytics
Hands-on leadership in early-phase or full clinical development strategies
Scientific publications or speaking engagements at statistical conferences
Experience mentoring and managing statistical teams (up to 8 team members)
Why Join Novartis?
Be part of a mission-driven organization that’s reimagining medicine and driving innovation through data science and collaboration. You’ll work in a culture that values scientific rigor, creativity, and global impact.
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📘 View Novartis Life Handbook – Benefits & Rewards
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