- Lead clinical data science activities from trial setup through analysis, submission, regulatory interactions, and preparation of regulatory submission documents
- Provide expertise on trial design components, including eCRFs, Data Flow Plans, Blinding Plans, protocols, and statistical analysis plans
- Ensure high-quality SDTM, ADaM, and TFL deliverables meeting industry standards and Novo Nordisk requirements
- Act as an operational partner within trial squads
- Support key data-driven decisions
- Collaborate with internal and external stakeholders, including contract research organisations and functional suppliers
- Drive efficient and compliant trial execution
- Drive continuous improvement, innovation, and knowledge sharing within Clinical Data Science
- Help shape future standards and ways of working
Requirements
- PhD or master’s degree in life sciences, natural sciences, engineering, or a related discipline
- More than two years of experience in statistical programming and clinical trial data analysis
- Experience preferably within the pharmaceutical industry
- Strong programming skills in R, SAS, or similar programming languages
- Experience with SDTM, ADaM, TFL generation, and regulatory submission deliverables
- Knowledge of clinical database technologies, data models, drug development processes, and Good Practice (GxP) requirements
- Experience collaborating across functions, geographies, and external partnerships
- Strong analytical and problem-solving skills
- Ability to manage multiple priorities simultaneously
- Excellent planning, organisational, communication, and stakeholder management skills
- Ability to explain technical topics to specialist and non-specialist audiences
- Continuous improvement mindset and genuine interest in innovation and new ways of working
- Fluency in written and spoken English
- Self-driven, accountable, and collaborative mindset
- Ability to work in multidisciplinary teams and take ownership of deliverables
Core Competencies
Demonstrates expertise in clinical data science, including statistical programming in R and SAS, and ensures high-quality deliverables such as SDTM, ADaM, and TFL for regulatory submissions. Possesses strong analytical, organizational, and communication skills to effectively collaborate with stakeholders and drive continuous improvement in trial execution.
Highest-signal resume keywords
- Statistical Programming in R
- Statistical Programming in SAS
- SDTM Deliverables
- ADaM Deliverables
- Regulatory Submission Experience
ATS Optimization Keywords
Hard Skills
- Statistical Programming
- Clinical Trial Data Analysis
- ECRFs
- Data Flow Plans
- Blinding Plans
- Protocols
- Statistical Analysis Plans
- GxP Requirements
- Data Models
- Drug Development Processes
Soft Skills
- Analytical Skills
- Problem-Solving Skills
- Planning Skills
- Organizational Skills
- Communication Skills
Industry Keywords
- Pharmaceutical Industry
- Regulatory Interactions
- Continuous Improvement
- Innovation
- Stakeholder Management
Tools & Technologies
- Clinical Database Technologies