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Senior Principal Biostatistician

3-7 years
Not Disclosed
10 June 16, 2025
Job Description
Job Type: Full Time Education: M.S/phD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Senior Principal Biostatistician at Novartis, Hyderabad

Job Summary:

Novartis is hiring a Senior Principal Biostatistician for its Hyderabad location to lead statistical activities across global clinical trials. This critical role ensures the design, development, and analysis of clinical trial data, offering expertise in innovative trial methodologies to support drug development projects. Ideal for experienced statisticians passionate about shaping the future of pharmaceutical research.


Key Responsibilities:

  • Lead all statistical tasks for assigned trials, including protocol development, statistical analysis plans, and reporting.

  • Provide expert guidance on innovative trial designs and exploratory analysis methodologies.

  • Ensure accurate interpretation and communication of statistical results to non-statistical teams.

  • Collaborate with regulatory, medical, and clinical teams for submission activities.

  • Drive the implementation of new statistical models and data exploration methods.

  • Oversee Biostatistics resources and ensure deliverables meet quality and regulatory standards.

  • Represent Novartis at external conferences, review boards, and scientific meetings.

  • Contribute to global line function initiatives and enterprise-level process improvements.


Required Skills & Qualifications:

  • PhD in Statistics (3+ years relevant experience) or MS in Statistics (7+ years experience).

  • Proficiency in statistical software packages such as SAS and R.

  • Expertise in clinical trial design, analysis, and regulatory requirements.

  • Solid understanding of pharmacokinetics, Bayesian statistics, and data exploration.

  • Excellent communication and matrix leadership skills.

  • Strong project management and cross-functional collaboration abilities.

  • Experience in drug development processes and health authority guidelines.


Perks & Benefits:

  • Competitive salary and performance incentives (compensation not specified).

  • Access to Novartis Life Handbook for personal and professional development.

  • Diverse and inclusive work environment.

  • Global exposure with opportunities to contribute at international forums.

  • Comprehensive health, wellness, and financial benefits.


Company Description:

Novartis is a leading global pharmaceutical company committed to reimagining medicine to improve and extend lives. Through scientific innovation and a collaborative work culture, Novartis delivers trusted and valued medicines worldwide, making a difference in the health of millions.


Work Mode:

On-site – Hyderabad, India


Call to Action:

Are you ready to make a global impact in drug development? Apply now to join Novartis as a Senior Principal Biostatistician and drive innovation in clinical research.