Role Overview
Associate Senior Clinical Data Scientist within Novo Nordisk Global Business Services (GBS), Clinical Data Science department in Bangalore. The role is an operational partner within clinical trial squads, responsible for critical clinical trial and cross-trial activities, statistical programming, clinical data management, regulatory deliverables, data standards, documentation, and programming quality throughout the clinical development lifecycle.
Core Clinical Trial Responsibilities
Manage assigned clinical-trial tasks and deliverables.
Finalize SDTM and ADaM deliverables.
Prepare and review annotated Case Report Forms (aCRFs).
Create Tables, Figures, and Listings (TFLs) in compliance with regulatory standards.
Contribute to trial setup activities, including development of electronic Case Report Forms (eCRFs), Data Flow Plans, metadata specifications, mock TFLs, SDRG, ADRG, and Define.xml.
Regulatory & Clinical Documentation
Support Clinical Study Reports (CSRs).
Support Risk Management Plans (RMPs).
Support Investigator Brochures (IBs).
Support Development Safety Update Reports (DSURs).
Support Periodic Safety Update Reports (PSURs).
Contribute to public disclosure deliverables.
Ensure programming and documentation practices comply with applicable clinical and regulatory standards.
Collaboration & Operational Excellence
Collaborate with internal and external stakeholders, including CROs, regulatory authorities, and scientific communities.
Support seamless clinical-trial execution across professional and regional boundaries.
Share best practices and contribute to process optimization.
Support change-management initiatives that improve data standards and programming practices.
Provide training and technical support to colleagues regarding statistical computing environments, system usage, and SOP understanding.
Technical & Quality Standards
Apply statistical programming expertise throughout the clinical development lifecycle.
Work with clinical database technologies, data models, and advanced programming techniques.
Use programming languages such as SAS or R.
Ensure documentation and programming practices meet Good Clinical Practice (GCP), Good Documentation Practice (GDP), and Good Programming Practice (GPP) standards.
Maintain high-quality clinical data and programming deliverables suitable for regulated clinical development activities.
Qualifications & Experience
Bachelor's or Master's degree in life sciences, natural sciences, engineering, or equivalent qualification.
2-3 years of programming experience, preferably involving biological data or equivalent practical experience.
Experience with clinical database technologies, data models, and advanced programming techniques.
Basic understanding of the pharmaceutical industry and the clinical development value chain.
Professional & Communication Skills
Strong analytical capability.
Ability to collaborate effectively across professional and regional borders in a multinational environment.
Independence, self-drive, and accountability.
Ability to manage variable workloads effectively.
Excellent written and spoken English communication skills.
Ability to explain technical issues clearly to peers and stakeholders.
Department & Business Impact
The role sits within Research & Development and the Clinical Data Science department in Novo Nordisk GBS Bangalore. The department has grown from a small start-up into one of the largest GBS units and contributes to Novo Nordisk's global clinical development portfolio. The team supports clinical drug development from early phases through product introduction, providing statistical analysis and programming expertise across clinical development activities.
Work Culture & Development
Work in a global healthcare and R&D environment focused on developing therapies for serious chronic diseases.
Collaborate with experienced programmers and colleagues bringing diverse perspectives.
Access continuous learning and professional development opportunities.
Work in a culture encouraging autonomy, employee voice, curiosity, and personal growth.
Participate in an inclusive recruitment environment with equality of opportunity for applicants.
Benefits are designed around career and life-stage needs.
