Novartis is seeking a Principal Biostatistician to provide statistical leadership and expert guidance in clinical development and global drug submissions. Based in Hyderabad, this role involves end-to-end statistical responsibilities for trials and regulatory submissions, fostering innovation in trial design and analytics, and driving data-driven decision-making within cross-functional global teams. Ideal for professionals with a PhD (3+ years) or MS (7+ years) in statistics and strong SAS/R proficiency, this is a unique opportunity to make a meaningful impact in advancing healthcare outcomes.
Independently lead statistical tasks for complex trials and projects
Develop and review statistical analysis plans and protocols
Provide statistical expertise for regulatory submissions and data interpretation
Collaborate with cross-functional teams across clinical, regulatory, programming, and medical writing
Represent Biostatistics in internal and external meetings, including interactions with Health Authorities
Drive innovation in trial design, including adaptive designs and Bayesian methodologies
Oversee deliverables and ensure quality control for statistical outputs
Contribute to global initiatives in data standards, infrastructure, and automation
Mentor junior statisticians and support continuous improvement
Education:
MS in Statistics or equivalent with 7+ years of experience
PhD in Statistics or equivalent with 3+ years of experience
Technical Skills:
Proficiency in SAS and R
Knowledge of CDISC standards, ICH guidelines, and regulatory requirements
Familiarity with pharmacokinetics, exposure-response modeling, and Bayesian methods (preferred)
Strong understanding of clinical trial methodology and drug development lifecycle
Effective communication and ability to explain complex statistical concepts to non-statisticians
Experience in health authority interactions, submission activities, and cross-functional collaboration
Competitive compensation package (Salary not disclosed)
Health and wellness benefits
Career development and learning support
Inclusion in global statistical innovation projects
Opportunity to work with cross-functional global clinical teams
Access to Novartis talent and mentorship networks
Inclusive and diverse workplace
Novartis Healthcare Pvt. Ltd. is a global leader in pharmaceuticals, pioneering breakthrough therapies that improve and extend lives. With a strong focus on innovation and data-driven drug development, Novartis operates at the forefront of healthcare advancement worldwide.
On-site – Hyderabad Office
Advance your career in clinical development and global submissions. Apply now to join Novartis and be part of a team transforming patient care through cutting-edge biostatistics.
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