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    Senior Principal Biostatistician

    Novartis
    2+ years
    Not Disclosed
    Hyderabad
    10 Nov. 6, 2024
    Job Description
    Job Type: Full Time 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

    Job Opportunity: Senior Principal Biostatistician at Novartis

    Location: Hyderabad, India
    Division: Development | Business Unit: Innovative Medicines
    Company: Novartis Healthcare Private Limited
    Job Type: Full-time | Employment Type: Regular

    At Novartis, we are committed to reimagining medicine and improving patient outcomes by leveraging cutting-edge science and technology. Our global team is at the forefront of developing breakthrough therapies for the world's most pressing health challenges. With a mission to touch the lives of millions, we need talented professionals like you to help us lead the way in transforming healthcare.

    We are looking for a Senior Principal Biostatistician to join our Innovative Medicines division in Hyderabad. In this role, you will provide leadership and expertise in statistical analysis for clinical trials, collaborating across functions to drive innovative trial designs and contribute to the overall success of development projects.

    About the Role:

    As a Senior Principal Biostatistician, you will be responsible for the statistical work for one or more clinical trials, providing scientific and operational leadership. You will work independently on trial-level tasks and, in some cases, lead statistical activities at the project level, providing innovative solutions to complex challenges. You will also play a key role in protocol development, statistical analysis plans, and submission activities.

    Key Responsibilities:

    1. Study-Level Responsibilities:

      • Lead all statistical tasks for assigned trials, including protocol development, statistical analysis planning, and reporting.
      • Provide statistical expertise and interpret results for Health Authority submissions and responses.
      • Collaborate with clinical teams to develop and implement exploratory analyses, including PK/PD, biomarkers, and other complex analyses.
      • Act as a key point of contact for external review boards, ethics committees, and other external partners.
      • Represent Novartis at scientific meetings, congresses, and conferences, sharing statistical expertise.
      • Ensure high-quality, timely statistical deliverables, contributing to the overall trial success.

    2. Project-Level Responsibilities:

      • Contribute to cross-functional teams, representing Biostatistics & Pharmacometrics in early-stage projects with a focus on quantitative decision-making.
      • Lead the implementation of innovative trial designs and dose-finding methods to optimize drug development.
      • Collaborate with regulatory, clinical, and other strategic teams to ensure statistical alignment and project success.
      • Play an active role in preparing for HA Advisory Committees and meetings, ensuring alignment on statistical methodologies.

    3. Global Line Function Contribution:

      • Drive initiatives to improve organizational processes and consulting within the Biostatistics & Pharmacometrics team.
      • Promote innovative statistical methods, presenting and publishing findings in scientific journals and at conferences.

    4. External Engagement:

      • Represent Novartis in external scientific discussions, offering insights into statistical designs and methodologies.
      • Contribute to industry thought leadership and best practices in clinical trial design and analysis.

    5. People Management & Mentoring:

      • Mentor new hires and junior statisticians, providing guidance on trial-level responsibilities and statistical methodologies.

    What You Will Bring to the Role:

    • MS in Statistics (or equivalent) with 7+ years of relevant experience, or a PhD in Statistics (or equivalent) with 3+ years of experience.
    • Proven ability to independently handle all statistical tasks at the trial/experiment level, including complex statistical methodologies such as pharmacokinetics, exposure-response modeling, and applied Bayesian statistics.
    • Proficiency in statistical software tools (e.g., SAS, R) and a deep understanding of drug development and Health Authority guidelines.
    • Strong experience in leading projects, including dose-finding and drug development optimization.
    • Excellent communication skills, with the ability to explain statistical concepts to non-statisticians and collaborate effectively across functions.
    • Good project management and matrix leadership skills, with the ability to guide cross-functional teams towards shared goals.

    Why Novartis?

    At Novartis, we believe that collaboration and innovative thinking are key to success. Our team works together to make a difference in the lives of patients around the world. As a Senior Principal Biostatistician, you will have the opportunity to lead impactful projects, contribute to the future of drug development, and collaborate with top-tier experts across the globe.

    Location:

    Hyderabad, India

    Company/Legal Entity:

    Novartis Healthcare Private Limited

    Functional Area:

    Research & Development

    Employment Type:

    Full-time, Regular

    Accessibility & Accommodation:

    Novartis is committed to providing reasonable accommodations for individuals with disabilities. If you need assistance during the recruitment process or need accommodations to perform essential job functions, please contact us at diversityandincl.india@novartis.com.

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