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Principal Biostatistician

3-7 years
Not Disclosed
10 July 1, 2025
Job Description
Job Type: Full Time 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

 

Principal Biostatistician – Clinical Trials | Novartis | Hyderabad, India

Job Summary:

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.


Key Responsibilities:

  • 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


Required Skills & Qualifications:

  • 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


Perks & Benefits:

  • 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


Company Description:

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.


Work Mode:

On-site – Hyderabad Office


Call-to-Action:

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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