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    Senior Clinical Data Scientist

    Novartis
    3-5 years
    Not Disclosed
    Hyderabad
    10 Nov. 27, 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

    Senior Clinical Data Scientist

    Location: Hyderabad, India (#LI-Hybrid)
    Job ID: REQ-10029989
    Company: Novartis Healthcare Private Limited
    Division: Development
    Business Unit: Innovative Medicines
    Functional Area: Research & Development

    About the Role

    The Senior Clinical Data Scientist is responsible for using advanced data management tools to provide professional execution of Data Management (DM) products for assigned trials within Clinical Data Acquisition and Management. This role ensures high-quality data is available for analysis and reporting and supports the overall success of clinical trials.

    Key Responsibilities

    • Leadership in Data Management:
      • Act as Trial Data Scientist for assigned trials, ensuring strong Data Management (DM) representation across the Clinical Trial Team (CTT).
      • Provide business insights into compound profiles and data strategy, ensuring proper application of DM processes and documentation.
    • Study Start-up and Protocol Support:
      • Perform DM activities during study start-up, including preparing architecture and conducting User Acceptance Testing (UAT).
      • Manage local lab data flow and set up the Clinical Database as needed.
    • Ongoing Study Management:
      • Lead data quality and integrity efforts, ensuring on-time delivery of study data.
      • Disseminate study-level information to the CTT and Program Clinical Data Scientist (PCDS).
      • Oversee third-party reconciliation activities and ensure adherence to ICH GCP, DM standards, SOPs, and process guidelines.
    • Innovation and Efficiency:
      • Provide input into DM initiatives aimed at improving quality, efficiency, and continuous improvement in scientific and operational excellence.
    • Progress Tracking and Reporting:
      • Track and report status for assigned trials and programs, ensuring adherence to timelines and regulatory requirements.

    Essential Requirements

    • Education: University degree in life science, computer science, pharmacy, nursing, or an equivalent field.
    • Experience:
      • Ideally, 5 years in Drug Development, with at least 4 years in Clinical Data Management.
    • Skills:
      • Strong leadership abilities with excellent interpersonal skills.
      • Proven ability to interrogate data and use various programming/GUI techniques.
      • Excellent problem-solving and verbal/written communication skills.

    Why Novartis?

    Novartis is committed to reimagining medicine to improve lives. The company values its people and fosters a collaborative, innovative environment to drive breakthroughs in healthcare.

    Benefits and Rewards

    Explore the full range of benefits and rewards for Novartis employees in the Novartis Life Handbook: Novartis LifeHandbook.

    Commitment to Diversity & Inclusion

    Novartis aims to build an inclusive environment that represents the diverse communities they serve, ensuring all employees have an opportunity to thrive.

    Join the Novartis Network

    If this role is not a fit for your skills but you'd like to stay informed about future opportunities, join the Novartis Talent Network: Novartis Talent Network.

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