Associate Director Biostatistics
Job ID: REQ-10052506
Location: Hyderabad, India
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Job Type: Full-time
Employment Type: Regular
Shift Work: No
Company: Novartis Healthcare Private Limited
Estimated Salary: ₹50–65 LPA
Summary:
The Associate Director Biostatistics will provide advanced expert support, functional and technical leadership in clinical development, early development, and research. The role includes developing and applying biostatistics methodologies for scientific validity, supporting regulatory submissions, and leading innovations in tools and systems for data analytics and standards.
Key Responsibilities:
Study Level:
Lead statistical activities for high-complexity trials with minimal supervision.
Develop protocols, statistical analysis plans (SAPs), and reports.
Support exploratory, PK/PD, biomarker, and pricing analyses.
Contribute to innovative trial design and dose-finding strategies.
Provide statistical expertise in regulatory submissions and interactions.
Represent Novartis in external statistical forums.
Collaborate cross-functionally and ensure line function awareness.
Manage timelines and quality for biostatistical deliverables.
Project Level:
Provide strategic statistical input for development plans, pricing strategies, and publications.
Collaborate with cross-functional teams to drive quantitative decision-making.
Facilitate project transitions from early to late development.
Oversee resource management and vendor collaboration.
Represent Biostatistics in regulatory and internal decision boards.
Disease Area/TA Level:
Act as a strategic partner to clinical leaders within assigned therapeutic areas.
Franchise/Global Line Function Level:
Lead initiatives at franchise or global levels requiring diverse team coordination.
Enterprise Level:
Contribute to cross-functional process improvements and due-diligence activities.
Promote innovative methods through publications, scientific meetings, and collaborations.
External Representation:
Represent the function in meetings with ethics boards, consultants, and professional forums.
People Management:
Recruit, mentor, and manage up to 8 biostatisticians.
Foster professional development and team leadership.
Role Requirements:
Education: MS in Statistics or equivalent with 10+ years, or PhD in Statistics or equivalent with 6+ years of experience.
Experience:
Advanced expertise in clinical trial statistics.
Strong statistical software proficiency (e.g., SAS, R).
Experience in pharmacokinetics, Bayesian methods, or biomarkers preferred.
Regulatory and drug development process knowledge.
Proven leadership of multidisciplinary teams.
Skills:
Strategic thinking, strong communication, and interpersonal skills.
Excellent mentoring and collaboration abilities.
Business acumen and ethical standards.
Why Novartis:
Novartis is driven by its purpose to reimagine medicine and improve lives. With an inclusive culture, innovative science, and dedicated teams, Novartis seeks passionate professionals who thrive in a collaborative environment. Learn more: Novartis Culture & Strategy
Benefits & Rewards:
Details available in the Novartis Life Handbook
Diversity & Inclusion:
Novartis promotes a diverse, inclusive, and equitable work environment. Reasonable accommodations are available for applicants with disabilities. Contact: diversityandincl.india@novartis.com (mention Job ID in your email).
Not the right fit?
Join the Novartis Talent Network to stay informed about future opportunities.
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