02 Aug
|
Novo Nordisk
|
Bengaluru
02 Aug
Novo Nordisk
Bengaluru
Job Summary
Transform clinical data into life-changing insights that bring breakthrough therapies to patients worldwide.
Job Details
Job Title: Senior Clinical Data Scientist
Department: Bangalore R&D;
Location: Novo Nordisk Global Business Services (GBS) India
Your new role
As a Senior Clinical Data Scientist, youll be the operational partner within trial squads, responsible for planning, managing and executing clinical data science contributions across clinical trials. Youll bridge the gap between complex data programming and clinical development, ensuring that every statistical analysis meets the highest industry standards and drives our mission to defeat serious chronic diseases.
Responsibilities
- Leading the clinical data science setup for trials, including eCRF design, Data Flow Plans, and Blinding Plans, while serving as the key operational partner within trial squads
- Ensuring quality control and compliance of SDTM and ADaM deliverables, managing submission packages and TFL generation according to industry standards and Novo Nordisk specifications
- Coordinating with stakeholders across R&D; to facilitate open learning sessions and share clinical data science expertise after each submission
- Providing critical input to authority-required documents including Risk Management Plans, Investigators Brochures, and Development Safety Update Reports
- Managing day-to-day trial execution, reviewing protocols and Statistical Analysis Plans, and contributing to the interpretation and communication of clinical trial results
- Overseeing effective collaboration with CROs and vendors,
ensuring inspection readiness documentation is maintained throughout the trial lifecycle
- Driving innovation by identifying better practices, creating improvements in methods and collaboration, and presenting at global knowledge-sharing forums
Your department In Research & Development, youll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs.
Youll join the Clinical Data Science Bangalore team, which has grown from a small start-up to one of the largest units in Global Business Services, Bangalore, and a key contributor to Novo Nordisks clinical development portfolio. With decades of experience, our team brings together seasoned programmers and fresh perspectives to ensure high-quality statistical analysis and programming support for all clinical development activities worldwide from early development phases to product introduction.
Your skills &
qualifications
Were looking for an analytical thinker who thrives in a quick-paced,
collaborative environment and can handle multiple priorities with precision. Youll bring:
- Bachelors or Masters degree in life sciences, natural sciences, engineering, or equivalent qualifications
- 3-5 years of statistical programming experience, with preferably 1 year within the pharmaceutical industry or equivalent relevant experience
- Extensive programming expertise in SAS or R, with proven experience in reporting clinical trials, including statistical data handling, analysis and reporting
- Strong knowledge of drug development, clinical database technologies, data models, and advanced programming techniques
- Experience with program review and documentation, along with in-depth understanding of GxP and guidelines within drug development
- Excellent planning and coordination skills, with the ability to manage variable workloads and handle numerous tasks simultaneously while maintaining systematic organization
- Outstanding communication skills in written and spoken English, with experience presenting to diverse audiences and collaborating across professional and regional borders
- Personal qualities including independence, self-drive, strong analytical thinking, commitment, persistence, and the ability to seek innovative solutions while keeping things simple
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
📌 Sr Clinical Data Scientist (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru