Senior Clinical Data Scientist - SDTM/ADaM Lead

Jobtailor; Søborg; On-site; DKK 1,200,000 - 1,800,000; Full time

Job summary

Novo Nordisk is seeking a lead clinical data scientist to drive data science activities across trials, from design to regulatory submission. You will own SDTM/ADaM/TFL deliverables and collaborate with CROs and stakeholders to ensure quality and compliance.

Role requires strong programming in R/SAS, GxP knowledge, and the ability to influence across geographies. A multidisciplinary, proactive, and communicative mindset is essential for success.

Qualifications

• PhD or master’s degree in life sciences, natural sciences, engineering, or 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 languages.
• Experience with SDTM, ADaM, TFL generation, and regulatory submission deliverables.
• Knowledge of clinical database technologies, data models, drug development processes, and GxP requirements.
• Experience collaborating across functions, geographies, and external partnerships.
• 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.

Responsibilities

• 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.

Skills

Analytical Skills

Problem-Solving Skills

Planning Skills

Organizational Skills

Communication Skills

Education

PhD or Master’s degree in life sciences, natural sciences, engineering

Tools

R

SAS

Clinical Database Technologies

Job description

Novo Nordisk is seeking a lead clinical data scientist to drive data science activities across trials, from design to regulatory submission. You will own SDTM/ADaM/TFL deliverables and collaborate with CROs and stakeholders to ensure quality and compliance.

Role requires strong programming in R/SAS, GxP knowledge, and the ability to influence across geographies. A multidisciplinary, proactive, and communicative mindset is essential for success.