Job Title: Associate Senior Clinical Data Scientist
Company: Novo Nordisk
Location: Bangalore, Karnataka, India
Employment Type: Full-time
Department: Clinical Data Science (Global Business Services)
Experience Required: 2–3 years of experience in Clinical Data Programming, Statistical Programming, or Clinical Data Science with proficiency in SAS or R.
Education: Bachelor's or Master's degree in Life Sciences, Natural Sciences, Engineering, Statistics, or a related field.
Salary Package: ₹10–16 LPA (Estimated as per current market standards; final compensation depends on experience, technical skills, and interview performance.)
Key Responsibilities:
Manage statistical programming tasks for assigned clinical trials.
Develop and finalize SDTM and ADaM datasets.
Prepare and review Annotated CRFs (aCRFs).
Program ADaM datasets and generate Tables, Figures, and Listings (TFLs).
Support trial setup activities including eCRFs, Data Flow Plans, metadata specifications, SDRG, ADRG, and Define.xml.
Contribute to Clinical Study Reports (CSR), Risk Management Plans (RMP), Investigator Brochures (IB), DSUR, PSUR, and public disclosure deliverables.
Collaborate with CROs, regulatory authorities, and cross-functional global teams.
Support process improvements and change management initiatives.
Train team members on statistical programming tools and SOPs.
Ensure compliance with GCP, GDP, GPP, and regulatory standards.
Required Skills:
SAS Programming
R Programming
Clinical Data Science
Statistical Programming
SDTM
ADaM
TFL (Tables, Figures & Listings)
Annotated CRFs (aCRFs)
Define.xml
SDRG & ADRG
Clinical Database Technologies
Clinical Trial Data Management
Metadata Specification
GCP, GDP & GPP Compliance
Analytical & Problem-Solving Skills
Stakeholder Management
Microsoft Office
Preferred Skills:
Experience with biological or clinical trial data.
Knowledge of clinical development lifecycle.
Experience working with CROs and global clinical teams.
Understanding of pharmaceutical regulatory requirements.
Exposure to clinical reporting and submission documentation.
Work Mode: Office-Based (Bangalore)
Benefits:
Competitive salary with performance-based growth.
Continuous learning and career development opportunities.
Exposure to global clinical development projects.
Collaborative and innovation-driven work culture.
Opportunity to work with one of the world's leading pharmaceutical companies.
Strong focus on employee growth, diversity, and inclusion.
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