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    Associate Director Biostatistics

    Novartis
    7+ 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: Associate Director, Biostatistics 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 the lives of millions of people globally. We are leveraging cutting-edge science and technology to develop breakthrough therapies for patients who need them the most. We are seeking a talented Associate Director, Biostatistics to join our team in Hyderabad and lead statistical strategy and innovation for clinical development programs.

    About the Role:

    As the Associate Director, Biostatistics, you will be responsible for leading the statistical strategy and operational planning for high-complexity clinical trials and programs. You will collaborate closely with cross-functional teams to drive data-driven decision-making, utilizing advanced statistical methods to influence drug development from early through full clinical phases. You will also mentor junior statisticians and play a key role in external scientific and regulatory discussions.

    Key Responsibilities:

    Study Level:

    • Lead statistical tasks for high-complexity clinical and non-clinical trials, including protocol development, statistical analysis plans, and reporting activities.
    • Drive the planning and execution of exploratory analyses, innovative methodologies, and dose-finding strategies in alignment with clinical goals.
    • Provide statistical expertise in regulatory submissions, meeting preparation with Health Authorities, and pricing & reimbursement submissions.
    • Act as a key liaison in interactions with external review boards, ethics committees, and consultants.
    • Represent Novartis at scientific meetings, congresses, and conferences to share statistical insights and innovations.
    • Ensure the quality and timeliness of statistical deliverables and resources for assigned trials.

    Project Level:

    • Provide strategic statistical input across development plans, regulatory strategy, and clinical programs.
    • Collaborate with clinical, regulatory, and strategic functions to drive quantitative decision-making and ensure robust drug development.
    • Contribute to the transition of projects from early to late-stage development, ensuring a seamless handover and continued support.
    • Drive innovative designs and methods to optimize drug development, with a focus on dose-finding and clinical trial design.
    • Represent Biostatistics in key internal and external decision-making bodies, including Health Authority meetings.

    Disease Area / Therapeutic Area Level:

    • Provide strategic statistical input and drive excellence in development programs within the assigned therapeutic area (TA).

    Global Line Function and Enterprise Level:

    • Contribute to global initiatives and cross-functional team activities, ensuring alignment with organizational goals and regulatory guidelines.
    • Promote the use of innovative methods through scientific publications, presentations, and collaborations.
    • Contribute to due-diligence processes for low- to mid-complexity in-licensing opportunities.

    External Engagement:

    • Represent Biostatistics at external conferences and lead sessions at scientific meetings.
    • Engage with external stakeholders, promoting Novartis' statistical leadership.

    People Management:

    • Mentor junior statisticians, fostering talent and driving professional development.
    • Responsible for recruiting, retaining, and developing up to 8 biostatisticians in the team.

    What You Will Bring to the Role:

    • MS in Statistics (or equivalent) with 10+ years of relevant work experience or a PhD in Statistics (or equivalent) with 6+ years of relevant work experience.
    • Proven expertise in applying statistics to clinical trials and drug development, with proficiency in statistical software (e.g., SAS, R).
    • Experience in pharmacokinetics, exposure-response modeling, exploratory biomarker analysis, or Bayesian statistics.
    • Strong knowledge of regulatory guidelines and drug development processes.
    • Leadership experience in managing teams, guiding projects, and influencing decisions across cross-functional teams.
    • Ability to mentor and coach junior staff, fostering a collaborative and innovative team environment.
    • Excellent communication skills with the ability to translate complex statistical concepts into actionable insights for non-statisticians.

    Why Novartis?

    At Novartis, we are driven by the mission to help people with disease and their families. Our collaborative, diverse, and passionate community works together to make a difference in the lives of patients around the world. As an Associate Director, Biostatistics, you will have the opportunity to lead impactful projects, contribute to the future of drug development, and work with top experts in the field.

    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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