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Cdisc Sdtm Adam Jobs in Indiana (NOW HIRING)

Cdisc Sdtm Adam information

What are the key skills and qualifications needed to thrive as a CDISC SDTM/ADaM Specialist, and why are they important?

To thrive as a CDISC SDTM/ADaM Specialist, you need a solid background in clinical data management, knowledge of regulatory standards, and expertise in statistical programming (often with SAS). Familiarity with CDISC SDTM and ADaM models, FDA submission requirements, and tools like Pinnacle 21 or JReview is typically required. Strong attention to detail, analytical thinking, and effective communication are essential soft skills for this role. These competencies ensure accurate data standardization, regulatory compliance, and smooth collaboration in clinical research environments.

What are the typical collaboration points between a CDISC SDTM/ADaM programmer and clinical data managers during a clinical trial project?

A CDISC SDTM/ADaM programmer works closely with clinical data managers to ensure data collected during a clinical trial is accurately mapped and transformed according to regulatory standards. Collaboration often involves clarifying data definitions, resolving data discrepancies, and aligning on timelines for data delivery. Regular meetings and clear communication are key, as programmers rely on data managers for clean, validated data, while data managers depend on programmers to structure data sets correctly for analysis and regulatory submission. This partnership is essential for meeting project deadlines and maintaining data integrity.

What are CDISC SDTM and ADaM?

CDISC SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) are data standards used in clinical trials to organize and submit data to regulatory agencies like the FDA. SDTM defines how to structure raw clinical trial data for submission, focusing on standardizing data tabulation. ADaM provides guidelines for creating datasets used in statistical analysis, ensuring the data is analysis-ready and traceable back to SDTM. Both standards improve data quality, consistency, and regulatory review efficiency in the pharmaceutical industry.

What is the difference between Cdisc Sdtm Adam vs Clinical Data Coordinator?

AspectCdisc Sdtm AdamClinical Data Coordinator
Primary RoleDevelops and manages ADaM datasets for clinical trialsOversees data collection, entry, and quality control in clinical studies
Required SkillsKnowledge of CDISC standards, SAS programming, statistical conceptsData management, database systems, attention to detail
Work EnvironmentPharmaceutical or CRO data analysis teamsClinical research sites, CROs, pharmaceutical companies

While Cdisc Sdtm Adam specialists focus on creating analysis datasets using CDISC standards, Clinical Data Coordinators manage the overall data collection and quality in clinical trials. Both roles require knowledge of clinical data processes but differ in their specific responsibilities and technical focus.

Applied AI Engineer, Clinical Informatics

Applied AI Engineer, Clinical Informatics

Eli Lilly and Company

Indianapolis, IN • On-site

Full-time

This job post has expired today. Applications are no longer accepted.


Eli Lilly and Company rating

8.8

Company rating: 8.8 out of 10

Based on 62 frontline employees who took The Breakroom Quiz

11th of 70 rated pharmaceutical


Job description

Job Summary:
Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and bringing life-changing medicines to those in need. They are seeking a highly specialized Applied AI Engineer Clinical Informatician to lead research at the intersection of clinical trial datasets and biobank-linked population data, building systems and tools for extracting and contextualizing patient phenotypes from various datasets.
Responsibilities:
• Develop and deploy agentic AI applications that enable natural language interaction with clinical data
• Ground AI outputs in validated biological knowledge, for example implementing RAG pipelines anchored in biomedical ontologies (HPO, Gene Ontology, MeSH, DrugBank), clinical trial registries, and curated pathway databases
• Deploy unsupervised and self-supervised learning approaches like clustering, representation learning, contrastive learning to discover latent patient archetypes and molecular disease subtypes across trial and biobank data
• Deploy survival models and dynamic treatment regime estimators using combined clinical and omics features
• AI tooling to harmonize heterogeneous trial and biobank datasets to common data representations
• Evaluate and monitor model performance, safety, and reliability in production environments
• Manage vendors and contractors as well as partner relationships with relevant teams across Lilly
• Building pipelines for locked clinical trial databases (SDTM, ADaM) to conduct secondary and exploratory research beyond primary endpoints
• Deploy ML workflows to identify trial subgroup effects, treatment heterogeneity, and responder/non-responder signatures from completed trial data
• Mine adverse event narratives, clinical notes, and investigator comments using NLP to surface latent safety signals not captured in structured endpoints in biobanks and clinical datasets
• Reconstruct patient-level longitudinal trajectories from trial visit data to model disease progression, drug response kinetics, and time-to-event outcomes
• Architect workflows for meta-analytic and cross-trial integrative analyses across multiple completed studies to identify generalizable biological and clinical patterns
• Build connections to large-scale biobank cohorts (UK Biobank, All of Us, etc.) as external validation and enrichment resources for trial-derived findings for clinical phenotypes
• Establish research data management practices ensuring full reproducibility of analyses including data versioning, containerized compute environments, and audit-ready analysis logs
• Ensure all research activities follow HIPAA, GDPR, and relevant IRB and ethics committee requirements
Qualifications:
Required:
• M.S. in Biomedical Informatics, Computational Biology, Bioinformatics, Statistical Genetics, Epidemiology, or a closely related quantitative field or an MD/PhD with equivalent depth in translational data science with 6+ years of research experience working with clinical trial datasets (SDTM/ADaM), biobank data, or large-scale population health data in an academic, pharmaceutical, or research institute setting
• Or Ph.D. in Biomedical Informatics, Computational Biology, Bioinformatics, Statistical Genetics, Epidemiology, or a closely related quantitative field or an MD/PhD with equivalent depth in translational data science with 3+ years of research experience working with clinical trial datasets (SDTM/ADaM), biobank data, or large-scale population health data in an academic, pharmaceutical, or research institute setting
Preferred:
• Demonstrated use of AI tools in production environments for clinical data analysis
• Expert proficiency in Python and/or R for statistical modelling and ML; strong command of SQL and experience with cloud-based research computing environments (ideally DNAnexus, AWS, GCP, Azure, or HPC clusters)
• Familiar with advanced generative AI methods like finetuning of LLMs. Building and training foundation models from scratch. High performance computing environments
• Deep knowledge of CDISC standards (SDTM, ADaM) and experience analyzing clinical trial databases for secondary research purposes
• Demonstrated experience applying ML methods including survival analysis, causal inference, NLP, and deep learning to clinical or genomic research questions
• Thorough understanding of OMOP CDM, HL7 FHIR Genomics, and major biomedical ontologies
• Direct research experience with major public and restricted-access biobank resources (UK Biobank, All of Us, etc.)
• Experience with federated learning, differential privacy, or secure computation frameworks applied to multi-site biomedical research
• Track record of peer-reviewed publications in clinical AI, translational informatics, genomics, or a related field
• Familiarity with the target trial framework and its application in biobanks
• Knowledge of pharmacogenomics, drug response modeling, or PK/PD data analysis from clinical trials
• Experience with knowledge graph construction, graph ML, or ontology-driven reasoning for biomedical discovery
• Hands-on experience with multi-omic data analysis
Company:
We're a medicine company turning science into healing to make life better for people around the world. Founded in 1876, the company is headquartered in Indianapolis, USA, with a team of 10001+ employees. The company is currently Late Stage.

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About Eli Lilly

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Eli Lilly, based in Indianapolis, IN, US, is one of the pioneers in the pharmaceutical industry with a rich history dating back to 1876. This global pharmaceutical company focuses on discovering, developing, manufacturing and selling pharmaceutical products in approximately 120 countries. The company's product categories include endocrinology, oncology, cardiovascular, neuroscience, and immunology. Having invested over $9 billion in research and development in the past decade, Eli Lilly is also committed to creating high-quality medicines that meet real needs. As a recipient of several awards and recognitions, Eli Lilly is known for its focus on life-saving research and drug development. Their mission is to make medicines that help people live longer, healthier, and more active lives.

Industry

Pharmaceutical product wholesalers

Company size

10,000+ Employees

Headquarters location

Indianapolis, IN, US

Year founded

1876