Senior Clinical Data Scientist

Lead clinical data science setup for trials, including eCRF design, Data Flow Plans, and Blinding Plans, serving as the operational partner within trial squads.

Manage quality control and compliance for SDTM and ADaM deliverables, submission packages, and TFL generation following industry standards and Novo Nordisk specifications.

Coordinate with R&D stakeholders to conduct open learning sessions and share clinical data science expertise following each submission.

Provide critical input to authority-required documentation such as Risk Management Plans, Investigator's Brochures, and Development Safety Update Reports.

Manage day-to-day trial execution, review protocols and Statistical Analysis Plans, and contribute to interpreting and communicating clinical trial results.

Oversee CRO and vendor collaborations, ensuring inspection readiness documentation is systematically maintained throughout the trial lifecycle.

Maintain strict adherence to GxP and regulatory guidelines governing global drug development and clinical data handling.

Leverage extensive programming expertise in SAS or R for reporting clinical trials, data modeling, and advanced statistical programming techniques.

Identify best practices and drive innovation in clinical database technologies, AI tools, and process workflows.

Represent Clinical Data Science in trial squads and present findings at global knowledge-sharing forums.

Drive operational excellence across clinical trial phases to deliver transformative therapies for serious chronic diseases.

Career opportunity within Novo Nordisk GBS India R&D unit with access to continuous learning and cross-therapy area collaboration.