Associate Sr Clinical Data Scientist

Job description

### Job Summary Associate Senior Clinical Data Scientist Drive life-changing innovation through data, where your programming expertise transforms clinical trials into breakthrough therapies for millions. Location: Bangalore, India ### Responsibilities - Managing assigned tasks within clinical trials, including finalizing SDTM and ADaM deliverables, preparing and reviewing annotated CRFs (aCRFs), generating SDTM datasets, programming ADaM, and creating TFLs in compliance with regulatory standards - Contributing to trial setup activities such as developing eCRFs, Data Flow Plans, metadata specifications, mock TFLs, SDRG, ADRG, and Define.xml - Supporting Clinical Study Reports (CSRs), Risk Management Plans (RMP), Investigator Brochures (IB), Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), and public disclosure deliverables - Collaborating with internal and external stakeholders including CROs, regulatory authorities, and scientific communities to ensure seamless trial execution - Sharing best practices, contributing to process optimization, and supporting change management initiatives that advance our data standards and programming practices - Providing training and support for colleagues on statistical computing environments, system usage, and SOP understanding - Ensuring all documentation and programming practices meet Good Clinical Practice (GCP), Good Documentation Practice (GDP), and Good Programming Practice (GPP) standards ### Your Department In Research Development, you'll 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. The Clinical Data Science department in Bangalore RD has evolved from a small start-up to one of the largest units in Global Business Services, becoming a key contributor to Novo Nordisk's clinical development portfolio worldwide. Our team brings together a powerful blend of experience and fresh perspective, with seasoned programmers forming the core. We manage clinical drug development from early phases through product introduction, ensuring the highest quality in statistical analysis and providing programming expertise that supports all clinical development activities across Novo Nordisk. ### Qualifications - Bachelor's or Master's degree in life sciences, natural sciences, engineering, or equivalent qualifications - 2-3 years of programming experience, preferably working with biological data or equivalent knowledge through relevant practical experience - Proficiency in programming languages such as SAS or R - Experience with clinical database technologies, data models, and advanced programming techniques - Demonstrated ability to collaborate effectively across professional and regional borders in a multinational environment - Strong analytical skills combined with independence, self-drive, and accountability in managing variable workloads - Excellent communication skills with fluency in written and spoken English, and the ability to explain technical issues to both peers and stakeholders - Basic understanding of the pharmaceutical industry and key elements of the clinical development value chain #### Experience Level Mid Level Disclaimer : This job posting & Location 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.