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Senior Clinical Data Scientist
Novo NordiskAssociate Senior Clinical Data Scientist supporting clinical trials with strong programming expertise. Managing tasks across clinical trials and collaborating with stakeholders to ensure quality standards.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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.
Benefits
Comp & perks- Opportunities to learn and develop
- Continuous learning opportunities
- Culture encourages autonomy
- Personal growth
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Programming ExperienceSDTM DeliverablesADaM ProgrammingAnnotated CRFs (aCRFs)TFL CreationClinical Database TechnologiesAdvanced Programming TechniquesMetadata SpecificationsMock TFLsDefine.xml
Soft Skills
Analytical SkillsIndependenceSelf-DriveAccountabilityExcellent Communication