Job Summary
Novartis is hiring a Principal Biostatistician to lead statistical planning, data analysis, and regulatory submission activities for global clinical development projects. Based in Hyderabad, this role is critical for ensuring scientific integrity and compliance with regulatory standards across clinical trials. Ideal for experienced biostatisticians with strong proficiency in SAS, R, and regulatory guidelines such as CDISC.
Key Responsibilities
Lead statistical tasks for mid- to high-complexity clinical trials.
Develop and review study protocols and statistical analysis plans.
Contribute to exploratory analyses, PK/PD modeling, and biomarker assessments.
Interpret analysis results and explain statistical methodologies to stakeholders.
Provide statistical expertise for health authority submissions and advisory meetings.
Represent Biostatistics in cross-functional teams and external scientific forums.
Ensure data integrity and regulatory compliance in all deliverables.
Innovate and implement advanced trial designs and statistical methods.
Support biostatistics initiatives at the global line function level.
Required Skills & Qualifications
MS in Statistics (7+ years) or PhD in Statistics (3+ years).
Expertise in clinical trial statistics, study design, and regulatory compliance.
Proficiency in SAS, R, and CDISC standards.
Strong understanding of pharmacokinetics, biomarkers, and Bayesian methods (preferred).
Effective communication and presentation skills.
Experience with cross-functional team collaboration.
Knowledge of global health authority guidelines and pharmaceutical development processes.
Perks & Benefits
Competitive salary (not specified in the description).
Career development opportunities in a global pharmaceutical leader.
Inclusive and diverse workplace environment.
Access to cutting-edge biostatistical tools and platforms.
Employee well-being programs and comprehensive health benefits.
Potential for involvement in industry conferences and scientific publications.
Company Description
Novartis is a global healthcare leader committed to developing breakthrough medicines and improving patient outcomes worldwide. With a focus on innovation, integrity, and inclusion, Novartis empowers its teams to drive scientific advancement and transform clinical research.
Work Mode
On-site (Hyderabad, India)
Call-to-Action
Ready to shape the future of clinical development? Apply now for the Principal Biostatistician role at Novartis and contribute to transforming global healthcare through data-driven insights. Visit Novartis Careers to submit your application today.
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