Clinical Data SME - data42

Major Accountabilities (Describe the 5-7 main results of the role to be achieved)

• Collaborate with data engineers, data scientists and other stakeholders to assess the feasibility of data requests based on key scientific questions and fulfil use-case specific data needs.
• Identify the relevant Clinical Data domains and variables based on use-case requirements and guide their interpretation and transformation—with an emphasis on pooling ADaM data across historical trials.
• Perform hands on activities to conduct data quality assessments to validate data prior to delivery.
• Share knowledge across the team on clinical trial data, transformation logic, and mapping strategies.
• Contribute to documentation to promote transparency in data transformation processes.
• Seek opportunities for continuous improvement.

Essential Requirements:

· 3-5 years of experience working with Clinical Trial data in a pharmaceutical or CRO setting (ideally within Neuroscience, Oncology, CRM or Immunology therapeutic areas). · Excellent knowledge of CDISC data standards (SDTM, ADaM) and familiarity with relevant data dictionaries (eg: MedDRA).

• Expertise in pooling Clinical Trial ADaM datasets.
• Experience in working with different legacy, historical, local data standards.
• Experience in working with clinical study documents (Protocol, CSR, etc.).
• Hands-on experience writing code for data transformations (eg: SQL, Python, R, etc.).
• Experience with SAS and PROC SQL.
• Have an analytical mindset and attention to detail.
• Ability to assess data quality, identify errors and inconsistencies.
• Demonstrated ability to work independently and as part of global Agile teams.
• Fluent in English (oral and written) with good communication skills.

Nice to have:

• Exposure to or interest in GenAI.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards