Clinical Data SME – Drive Innovation in Drug Discovery at Novartis data42
Summary:
Are you a data-driven professional with a passion for transforming clinical trial data into actionable insights? Novartis data42 is seeking a talented and experienced Clinical Data Subject Matter Expert (SME) to join our dynamic team. In this role, you will be instrumental in supporting our cutting-edge data science and AI initiatives, accelerating drug discovery and development. If you possess a strong background in clinical trial data, CDISC standards, ADaM pooling, and programming skills in SAS, Python, or SQL, we encourage you to apply and be a part of our innovative journey.
About Novartis data42:
Novartis data42 is at the forefront of leveraging data science and artificial intelligence to revolutionize drug discovery and development. Our platform drives innovation across the R&D pipeline, enabling faster, more efficient, and data-informed decision-making. We foster a collaborative and intellectually stimulating environment where talented individuals can thrive and make a significant impact on global healthcare.
The Role:
As a Clinical Data SME, you will serve as the primary data expert for clinical trials, working closely with data engineers, data scientists, and global stakeholders. Your expertise will be crucial in ensuring the accuracy, integrity, and readiness of datasets used for advanced analytics and evidence generation in R&D. This is an exciting opportunity to contribute to the development of life-changing therapies by harnessing the power of clinical data.
Key Responsibilities:
- Collaborate with cross-functional teams to assess data feasibility and define use-case requirements for various research projects.
- Identify relevant clinical data domains and ADaM variables to address specific scientific questions.
- Provide guidance on data transformations, interpretation, and mapping logic to ensure data accuracy and consistency.
- Perform thorough data quality assessments to validate datasets before delivery, identifying and resolving any discrepancies or issues.
- Share your deep knowledge of CDISC standards (SDTM, ADaM), ADaM pooling techniques, and data governance principles with the team.
- Contribute to the creation and maintenance of comprehensive documentation outlining transformation processes and data lineage.
- Proactively drive continuous improvement initiatives across data workflows, streamlining processes and enhancing data quality.
Essential Qualifications:
- Bachelor’s or Master’s degree in a relevant field such as biostatistics, computer science, or a life science discipline.
- 3-5 years of hands-on experience working with clinical trial data in a pharmaceutical company or CRO setting.
- In-depth knowledge of CDISC SDTM and ADaM standards, including practical experience in implementing these standards.
- Strong understanding of MedDRA terminology and experience in applying it to clinical data.
- Expertise in pooling ADaM datasets across historical clinical trials to enable comprehensive analyses.
- Familiarity with legacy data standards and experience working with clinical study documents such as Protocols and Clinical Study Reports (CSRs).
- Proficiency in programming languages such as SQL, Python, and R, with a strong ability to perform data manipulation and analysis.
- Experience with SAS programming, including PROC SQL, for data extraction, transformation, and loading (ETL) processes.
- Exceptional analytical skills, with a keen eye for detail and a commitment to ensuring data quality.
- Proven ability to work effectively in global Agile teams, collaborating with colleagues from diverse backgrounds.
- Excellent communication skills in English, both written and verbal, with the ability to clearly convey technical concepts to non-technical audiences.
Nice to Have:
- Exposure to or a strong interest in Generative AI (GenAI) and AI-driven data workflows.
- Experience with cloud-based data platforms and tools.
Why Join Novartis data42?
- Be at the forefront of innovation: Work on groundbreaking AI and data science initiatives that are transforming the pharmaceutical industry.
- Collaborate with experts: Engage with a global team of talented professionals across R&D, fostering a culture of learning and collaboration.
- Make a real impact: Your work will directly contribute to accelerating drug discovery and improving clinical R&D analytics, ultimately benefiting patients worldwide.
- Competitive compensation and benefits: Enjoy a competitive salary package and a comprehensive benefits program that supports your well-being.
- Culture of innovation: Thrive in an environment that encourages innovation, continuous learning, and scientific excellence.
Location:
Hyderabad (On-site)
How to Apply:
If you are a highly motivated and experienced Clinical Data SME with a passion for driving innovation, we encourage you to apply. Please submit your resume and cover letter through our online application portal. We look forward to hearing from you!