30 Jul
|
Novo Nordisk
|
Bengaluru
30 Jul
Novo Nordisk
Bengaluru
Company – Global Business Services, IndiaDepartment – Clinical Data ScienceLocation – Bangalore, India Drive life-changing innovation through data, where your programming expertise transforms clinical trials into breakthrough therapies for millions. Your new role As an Associate Senior Clinical Data Scientist, you'll be a key operational partner within trial squads, managing critical tasks across clinical trials and cross-trial activities that directly support our mission to defeat serious chronic diseases. Your technical expertise will ensure the highest quality standards in statistical programming and data management throughout the clinical development lifecycle.Day-to-day your tasks will include: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 standardsContributing to trial setup activities such as developing eCRFs, Data Flow Plans, metadata specifications, mock TFLs, SDRG, ADRG,
and Define.xmlSupporting Clinical Study Reports (CSRs), Risk Management Plans (RMP), Investigator Brochures (IB), Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), and public disclosure deliverablesCollaborating with internal and external stakeholders including CROs, regulatory authorities, and scientific communities to ensure seamless trial executionSharing best practices, contributing to process optimization, and supporting change management initiatives that advance our data standards and programming practicesProviding training and support for colleagues on statistical computing environments, system usage, and SOP understandingEnsuring all documentation and programming practices meet Valuable Clinical Practice (GCP), Good Documentation Practice (GDP), and Good Programming Practice (GPP) standards Your new department In Research & Development, you'll be part of a unit that ex
📌 Associate Senior Clinical Data Scientist (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru