Job Title: Senior Principal Biostatistician
Job ID: REQ-10024692
Location: Hyderabad, India
Company: Novartis Healthcare Private Limited
About the Role
The Senior Principal Biostatistician is responsible for leading all statistical activities for assigned clinical trials. You will work independently at the trial level and potentially lead statistical activities for larger development projects. This role requires you to propose and implement innovative trial designs, statistical models, and analysis methodologies. You will collaborate with the clinical trial team and represent Novartis at external scientific events.
Key Responsibilities
Study Level:
Oversee statistical tasks for mid- to high-complexity trials and provide guidance on protocol development, statistical analysis plans, and reporting.
Contribute to exploratory analyses, pharmacokinetic (PK), pharmacokinetic/pharmacodynamics (PK/PD), and biomarker analyses.
Explain statistical methodologies and interpret results.
Support submission activities and respond to Health Authorities when required.
Represent Novartis at scientific meetings and collaborate with external review boards or ethics committees.
Collaborate with cross-functional teams and communicate statistical concepts to non-statisticians.
Project Level:
Lead biostatistics for low-complexity programs and contribute to the development plan with oversight.
Drive quantitative decision-making in collaboration with clinical and regulatory teams.
Propose innovative methods for optimizing drug development.
Work with vendors to ensure quality and timeliness of statistical deliverables.
Franchise/Global Line Function Level:
Contribute to initiatives at the global line function level, including process and organizational improvements.
Promote innovative methods through scientific collaborations and publications.
External Level:
Represent Novartis in statistical discussions at congresses, conferences, and other scientific meetings.
People Management:
Mentor new hires and junior statisticians, fostering a collaborative environment.
Minimum Requirements
Education: MS in Statistics (or equivalent) with 7+ years of relevant experience or PhD in Statistics with 3+ years of relevant experience.
Proven expertise in all aspects of statistics, including trial-level statistical tasks and the application of statistical designs to clinical trials.
Experience in pharmacokinetics, exposure-response modeling, or applied Bayesian statistics may be required depending on the assignment.
Proficiency with statistical software packages (e.g., SAS, R).
Strong understanding of drug development and Health Authority guidelines.
Ability to collaborate effectively within multidisciplinary teams.
Good project management and leadership skills.
Why Novartis?
Novartis values collaboration and innovation in its mission to improve and extend people's lives. The company offers a supportive, inclusive environment where passionate individuals work together to achieve breakthroughs in healthcare.
Diversity & Inclusion: Novartis is committed to fostering a diverse and inclusive work culture.
Benefits & Rewards: Discover the benefits and rewards available to employees.
How to Apply
To apply, visit the Novartis Career Portal and submit your application.
Additional Information
Accessibility: Novartis is dedicated to providing reasonable accommodations during the recruitment process for individuals with disabilities. For assistance, contact diversityandincl.india@novartis.com.
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