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Principal Biostatistician

3-7 years
Not Disclosed
10 June 12, 2025
Job Description
Job Type: Hybrid Education: MS or 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

 

Job Title:

Principal Biostatistician – Novartis

Location:

Hyderabad, India (Hybrid)

Job Summary:

Novartis is hiring a skilled Principal Biostatistician to lead and deliver statistical analysis and data reporting for global clinical trials. This hybrid role in Hyderabad is ideal for candidates with a PhD or MS in Statistics and extensive experience in clinical development, regulatory submissions, and innovative statistical methods. Join a global healthcare leader to shape drug development and improve patient outcomes.


Key Responsibilities:

  • Lead statistical tasks for mid to high-complexity clinical trials, from protocol to reporting.

  • Develop statistical analysis plans, perform exploratory and PK/PD analyses.

  • Contribute to clinical development plans and execution of innovative trial designs.

  • Provide expert statistical input for regulatory submissions and health authority meetings.

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

  • Collaborate cross-functionally with data management, programming, and medical writing teams.

  • Oversee Biostatistics resources, ensuring timely and high-quality deliverables.

  • Drive novel methodologies and automation to optimize data analysis processes.

  • Train and mentor junior statisticians and support cross-functional initiatives.


Required Skills & Qualifications:

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

  • Strong expertise in biostatistics applications for clinical trials.

  • Proficiency in SAS, R, and other statistical software.

  • Excellent understanding of clinical development, regulatory requirements, and health authority guidelines.

  • Proven knowledge in PK/PD modeling, Bayesian statistics, biomarkers, and diagnostics (as applicable).

  • Strong project management, communication, and team collaboration skills.

  • Fluent in English (oral and written).


Perks & Benefits:

  • Competitive salary package (Not specified).

  • Comprehensive rewards and benefits as per Novartis Life Handbook.

  • Opportunities for global career growth and learning.

  • Inclusive, diverse, and collaborative work environment.

  • Flexible hybrid work mode from Hyderabad office.

  • Support for work-life balance, wellness, and professional development.


About Novartis:

Novartis is a leading global healthcare company committed to reimagining medicine and improving patient lives. With a presence in over 140 countries, Novartis is at the forefront of developing innovative therapies and drug solutions that impact millions worldwide.


Work Mode:

Hybrid (Hyderabad, India)


Call to Action:

If you are an experienced biostatistician passionate about clinical research and statistical innovation, apply now to join Novartis and shape the future of medicine!