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    Senior Principal Biostatistician

    Novartis
    3-7 years
    Not Disclosed
    Remote
    10 Oct. 9, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Summary
    The Senior Principal Biostatistician is accountable for all statistical work—both scientific and operational—across one or more assigned clinical trials. This role operates independently at the trial level and may lead statistical activities for a development project with limited supervision. The Senior Principal Biostatistician will propose and implement innovative trial designs, statistical models, and data exploration methodologies.

    About the Role

    Major Accountabilities

    1. Study Level:

      • Oversee all statistical tasks for assigned trials, managing mid- to high-complexity trials independently, while ensuring peer review as necessary. Develop protocols and statistical analysis plans in alignment with the development plan, and contribute to exploratory analyses and statistical consultations.
      • Communicate statistical methodologies and interpret analysis results to support submission activities and interactions with Health Authorities.
      • Engage with external review boards, ethics committees, and consultants, representing Novartis at scientific meetings and conferences.
      • Collaborate with cross-functional teams to ensure alignment and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team.
      • Ensure quality and timeliness of all Biostatistics deliverables for assigned trials.

    2. Project Level:

      • Participate as a core member in early project teams for low-complexity programs, collaborating with clinical, regulatory, and strategic functions to drive quantitative decision-making.
      • Work cross-functionally with data management, programming, and medical writing to ensure quality statistical deliverables.
      • Propose innovative designs and methods to optimize drug development processes.

    3. Franchise or Global Line Function Level:

      • Contribute to initiatives at the global line function level, enhancing collaboration and innovation.

    4. Enterprise Level:

      • Actively engage in organizational improvement initiatives and contribute to the review of health authority guidance.

    5. External Level:

      • Represent Novartis in external statistical discussions, contributing to interactions with regulatory bodies and ethical committees.

    6. People Management:

      • Mentor new hires and junior statisticians, fostering a culture of continuous learning.

    Minimum Requirements:

    • MS in Statistics or equivalent with 7+ years of relevant experience, or a PhD in Statistics or equivalent with 3+ years of relevant experience.
    • Proven ability to influence decisions impacting trial outcomes and project delivery.
    • Experience across all statistical tasks at the trial level, demonstrating independence and expertise in clinical trial statistics. Proficiency in statistical software (e.g., SAS, R) is essential.
    • Strong knowledge of drug development and regulatory guidelines, alongside effective collaboration in multidisciplinary teams.
    • Good understanding of therapeutic areas and regulatory activities, with solid project management skills.

    Join our Novartis Network:
    If this role does not align with your experience or career goals, consider joining the Novartis Network to stay informed about future opportunities: Novartis Talent Network.

    Why Novartis:
    At Novartis, we believe that improving lives requires a community of dedicated individuals. Collaborate with us to achieve breakthroughs that transform patient outcomes. Ready to make a difference? Learn more: Novartis People and Culture.

    Benefits and Rewards:
    Discover how we support your personal and professional growth in our Benefits Handbook.

    Division: Development
    Business Unit: Innovative Medicines
    Location: India
    Site: Hyderabad (Office)
    Company/Legal Entity: Novartis Healthcare Private Limited
    Functional Area: Research & Development
    Job Type: Full-time
    Employment Type: Regular
    Shift Work: No

    Accessibility and Accommodation:
    Novartis is committed to providing reasonable accommodations for individuals with disabilities during the recruitment process. For assistance, please contact diversityandincl.india@novartis.com.

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