Overview
Remote
Up to $70
Contract - Independent
Contract - W2
Contract - 12 Month(s)
Skills
Artificial Intelligence
Auditing
CDISC
Clinical Trials
Collaboration
Conflict Resolution
Data Management
Data Mapping
Data Structure
Machine Learning (ML)
Mapping
Meta-data Management
Natural Language Processing
Pharmaceutics
Problem Solving
Python
Regulatory Compliance
SDTM
XML
Job Details
Title: c (SDTM/CDISC, AI/ML)
Location: Remote
Duration: Long Term
Experience: 9+ Years
Requirement:
1. Must already be familiar with SDTM/CDISC clinical data standards
2. MUST have a pharma environment/industry experience.
3. Previous experience implementing scalable AI solutions is ideal
About the Role
We are seeking a talented Python Developer with experience in clinical data standards (SDTM/CDISC) and a passion for AI/ML-driven automation. In this role, you will design and implement scalable solutions to automate the transformation of raw clinical trial data into SDTM-compliant datasets, reducing manual effort and increasing efficiency.
Key Responsibilities
Design and develop automation pipelines for SDTM dataset generation using Python.
Build and deploy AI/ML models to streamline data mapping, domain identification, and controlled terminology matching.
Automate metadata-driven data transformations based on CDISC/SDTM standards.
Collaborate with cross-functional teams (clinical programming, data management, biostats) to gather requirements and ensure regulatory compliance.
Create reusable Python libraries and tools to support automation across multiple studies.
Implement validation checks, quality controls, and audit trails to ensure SDTM compliance and traceability.
Stay current with CDISC standards, regulatory guidelines (e.g., FDA), and AI/ML best practices.
Required Qualifications
Master s degree with 8+ years of experience in clinical or pharma settings and 3+ years of experience in Python development
Strong understanding of SDTM standards and CDISC requirements.
Experience with AI/ML techniques, including data preprocessing, classification, and NLP (e.g., for mapping clinical terms).
Familiarity with tools like Pinnacle 21, Define.xml, and clinical trial data structures.
Excellent problem-solving and collaboration skills.
Experience working with clinical trial datasets (ADaM, SDTM, raw).
Prior work on automation frameworks or metadata-driven data pipelines.
Knowledge of regulatory submission processes and FDA expectations for e-submissions
Location: Remote
Duration: Long Term
Experience: 9+ Years
Requirement:
1. Must already be familiar with SDTM/CDISC clinical data standards
2. MUST have a pharma environment/industry experience.
3. Previous experience implementing scalable AI solutions is ideal
About the Role
We are seeking a talented Python Developer with experience in clinical data standards (SDTM/CDISC) and a passion for AI/ML-driven automation. In this role, you will design and implement scalable solutions to automate the transformation of raw clinical trial data into SDTM-compliant datasets, reducing manual effort and increasing efficiency.
Key Responsibilities
Design and develop automation pipelines for SDTM dataset generation using Python.
Build and deploy AI/ML models to streamline data mapping, domain identification, and controlled terminology matching.
Automate metadata-driven data transformations based on CDISC/SDTM standards.
Collaborate with cross-functional teams (clinical programming, data management, biostats) to gather requirements and ensure regulatory compliance.
Create reusable Python libraries and tools to support automation across multiple studies.
Implement validation checks, quality controls, and audit trails to ensure SDTM compliance and traceability.
Stay current with CDISC standards, regulatory guidelines (e.g., FDA), and AI/ML best practices.
Required Qualifications
Master s degree with 8+ years of experience in clinical or pharma settings and 3+ years of experience in Python development
Strong understanding of SDTM standards and CDISC requirements.
Experience with AI/ML techniques, including data preprocessing, classification, and NLP (e.g., for mapping clinical terms).
Familiarity with tools like Pinnacle 21, Define.xml, and clinical trial data structures.
Excellent problem-solving and collaboration skills.
Experience working with clinical trial datasets (ADaM, SDTM, raw).
Prior work on automation frameworks or metadata-driven data pipelines.
Knowledge of regulatory submission processes and FDA expectations for e-submissions
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.