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    Lead SDTM Programmer - Bengaluru, India - Novo Nordisk A/S

    Novo Nordisk A/S
    Novo Nordisk A/S Bengaluru, India

    2 weeks ago

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    Description

    Department:

    Study Data Tabulation Model Programming & SubmissionDoes your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you.

    Apply now and join a growing team, working in an international environment.


    About the departmentGlobal Business Service (GBS), Study Data Tabulation Model Programming & Submission team was established in April 2016 and became a separate department in July 2021.

    The team has a good blend of experience and fresh perspective and comprises experienced SDTM Subject Matter and Submission experts, who form the core of the team.

    The main purpose & objective are to ensure high-quality compliant submission-ready SDTM packages in close collaboration with our stakeholders across the clinical landscape, for all clinical trials within Novo Nordisk.


    The PositionThe Lead Study Data Tabulation Model Programmer holds a pivotal role in ensuring adherence to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), Good Documentation Practice (GDP), and Good Programming Practice (GPP) within the organization.

    Recognized as a key figure in supporting end users, the Lead SDTM Programmer operates independently while aligning with the strategic objectives of standards governance bodies and the company at large.

    Additionally responsible for resolving methodological or technically demanding tasks, where innovation serves as a critical element.

    This multifaceted position requires a blend of technical proficiency, strategic vision, and effective communication skills to ensure the smooth functioning of data management processes and uphold regulatory compliance standards.

    Ensure design for clinical trials is aligned across trials within projects.
    Create the Study Data Tabulation Model (SDTM) submission package and post it to the publishing environment.
    Must have presented at conferences (within and outside India) and have a strong network within the pharmaceutical industry.
    Should have experience driving cross-functional initiatives with diverse stakeholders.
    Should have strong interpersonal capabilities to lead projects and people.

    QualificationsBachelors or Master in life sciences, natural sciences, pharmacy, veterinary science, engineering, clinical information management, computer science, or equivalent qualificationsMinimum 6-8 years of experience in the Life Sciences industry and preferably 4 years within Clinical Data Management and with hands-on experience in Clinical Data Interchange Standards Consortium (CDISC) SDTM.Expert knowledge of end-to-end clinical data management activities and computer systems involved in clinical data management.

    Experience with programming languages, eg. SAS, R, Python, AI/MLExtensive experience with collaboration across professional and regional borders.
    Experience with communication and presentations.
    Experience in mentoring.
    Participation in conferences/workshops.
    Demonstrated experience with project management and stakeholder management.
    Profound knowledge of GxP and guidelines within drug development and regulatory activities.

    About Novo NordiskNovo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases.

    Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily.

    All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world.

    We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them.

    Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us Together, we go further. Together, we're life-changing.
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