Clinical Data SME

1 day ago

Hyderabad, Telangana, India Novartis Full time

Job Description Summary

Job Purpose (State in one sentence the overall objective of the role)

Are you a Clinical Data SME who enjoys transforming complex trial data into analysis-ready assets that drive scientific progress? Join our data42 team

The vision of data42 is to inspire collaborative groundbreaking data and AI initiatives, to reimagine drug discovery at Novartis and accelerate time to market, ultimately transforming healthcare and improving lives.

As a Clinical Data SME, you'll be the go-to expert for clinical trial data. You'll work closely with data engineers and data scientists to assess feasibility, guide transformations and ensure data quality—so researchers can rely on trusted evidence to advance the science and deliver meaningful impact for patients

Job Description

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.

Skills Desired

Clinical Data Management, Databases, Data Governance, Data Integrity, Data Management, Data Quality, Data Science, Waterfall Model

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