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Sdtm Programmer Jobs in Raleigh, NC (NOW HIRING)

LivaNova

Statistical Programmer II

Raleigh, NC

$90K - $100K/yr

Contribute to the creation, validation, and documentation of SDTM and ADaM datasets. * Responsible for producing programming outputs, validation, and related documentation to ensure accuracy ...

IQVIA

Mgr, Database Management Systems

Durham, NC

Experience in Industry Standards (e.g., CDISC) in either the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models. * At least 8 years of clinical database developer experience in Rave ...

IQVIA

Mgr, Database Management Systems

Durham, NC · On-site

Experience in Industry Standards (e.g., CDISC) in either the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models. * At least 8 years of clinical database developer experience in Rave ...

micro1 AI

Director of Biostatistics

Durham, NC · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

micro1 AI

Director of Biostatistics

Cary, NC · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

micro1 AI

Director of Biostatistics

Raleigh, NC · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

micro1 AI

Director of Biostatistics

Durham, NC · Remote

$60 - $65/hr

Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets. * Solid understanding of statistical methods used in ...

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How much do sdtm programmer jobs pay per hour?

As of Sep 15, 2026, the average hourly pay for sdtm programmer in Raleigh, NC is $38.43, according to ZipRecruiter salary data. Most workers in this role earn between $25.00 and $50.00 per hour, depending on experience, location, and employer.

What is an SDTM programmer?

An SDTM Programmer is responsible for converting clinical trial data into standardized Study Data Tabulation Model (SDTM) datasets as per CDISC (Clinical Data Interchange Standards Consortium) guidelines. They ensure that data is structured and formatted correctly for regulatory submissions to agencies like the FDA or EMA. Their work involves writing SAS programs, validating datasets, and collaborating with clinical teams to ensure compliance and accuracy. Strong knowledge of SDTM standards, SAS programming, and clinical trial processes is essential for this role.

What are the typical daily responsibilities of an SDTM programmer?

SDTM Programmers are primarily responsible for transforming raw clinical trial data into standardized SDTM domains using programming languages like SAS. On a daily basis, you may be involved in mapping study data to SDTM specifications, validating the datasets, resolving discrepancies with data management teams, and documenting your processes for regulatory review. Collaboration with biostatisticians, clinical data managers, and quality assurance teams is also a significant part of the role. These responsibilities ensure that clinical data is accurate, compliant with industry standards, and prepared for analysis and submission to regulatory agencies.

What are the key skills and qualifications needed to thrive in the SDTM programmer position, and why are they important?

To thrive as an SDTM Programmer, you need a strong background in clinical data management, data standards (especially CDISC SDTM), and programming skills—typically in SAS. Familiarity with SDTM mapping, data validation tools, and relevant regulatory submission platforms or certifications (e.g., SAS Certified Clinical Trials Programmer) is highly valuable. Strong attention to detail, analytical thinking, and effective communication enable collaboration with clinical teams and accurate data interpretation. These skills ensure clinical trial data is accurately standardized, regulatory-compliant, and ready for analysis, which is critical to successful drug development processes.

What are the most commonly searched types of Sdtm Programmer jobs in Raleigh, NC?

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Sdtm Programmer jobs near you
Infographic showing various Sdtm Programmer job openings in Raleigh, NC as of September 2026, with employment types broken down into 100% Full Time. Highlights an 56% In-person, and 44% Remote job distribution, with an average salary of $79,939 per year, or $38.4 per hour.

Statistical Programmer / Clinical Data Architect

Raleigh, NC • On-site

Volto USA
See more jobs at Volto USAexternal

Contractor

Re-posted 14 days ago

Job description

Job Description: Local to Raleigh, NC  Only!
Role Overview
We are seeking a highly experienced Senior Statistical Programmer / Clinical Data Architect with 15+ years of expertise in clinical data programming, CDISC standards, and cloud-based analytics platforms. The ideal candidate will lead end-to-end clinical data workflows, regulatory submissions, and modern data platform transformations in GxP-regulated environments.
This role requires strong domain expertise in SDTM, ADaM, regulatory submissions, and SAS/Python/R programming, combined with experience in cloud platforms (AWS/Azure) and clinical data modernization initiatives.
________________________________________
Key Responsibilities
Clinical Data Programming & Regulatory Submissions
•       Design, develop, and validate SDTM and ADaM datasets in compliance with CDISC standards
•       Lead generation of define.xml, aCRF/eCRF annotations, and submission-ready deliverables
•       Develop and optimize automated submission pipelines for FDA and global regulatory authorities
•       Ensure compliance with GxP, 21 CFR Part 11, HIPAA, and ICH E6 guidelines
Data Engineering & Automation
•       Architect and implement end-to-end clinical data pipelines using SAS, Python, and R
•       Develop reusable SAS macro libraries and automation frameworks
•       Build scalable data pipelines including modern formats (JSON/XPT alternatives)
•       Drive migration from legacy systems to modern data architectures
Cloud & Platform Engineering
•       Lead implementation and optimization of SAS Viya platforms on AWS/Azure
•       Manage cloud infrastructure components (EKS, EC2, EFS, FSx, Databricks, etc.)
•       Implement FinOps practices for cost governance and optimization
•       Evaluate and onboard next-gen analytics platforms (e.g., Databricks)
Leadership & Stakeholder Management
•       Lead cross-functional teams across US, UK, and offshore locations
•       Collaborate with clinical, statistical, regulatory, and IT stakeholders
•       Drive Agile delivery and sprint planning for data and platform initiatives
•       Manage vendor relationships, tool selection, and licensing strategies
Compliance & Governance
•       Ensure adherence to regulatory and audit requirements (FDA, OCC, SOX, Basel III as applicable)
•       Maintain audit-ready documentation and validation processes
•       Implement data governance, traceability, and reproducibility standards
________________________________________
Required Qualifications
•       Bachelor’s or Master’s degree in Computer Science, Statistics, Life Sciences, or related field
•       15+ years of experience in statistical programming and clinical data management
•       Strong expertise in:
o       SAS (Base, Macro, SQL, ODS, STAT, Graph)
o       CDISC standards (SDTM, ADaM, define.xml)
o       Regulatory submissions (FDA, global agencies)
•       Hands-on experience with:
o       Python (Pandas) and/or R (admiral, Shiny)
o       Cloud platforms (AWS/Azure)
•       Strong understanding of GxP and clinical compliance frameworks
________________________________________
Preferred Qualifications
•       Experience with SAS Viya architecture and administration
•       Familiarity with Databricks, DBT, or modern data engineering tools
•       Knowledge of CI/CD tools (Jenkins, Git)
•       Experience in financial/regulatory environments (Basel III, CCAR, OCC) is a plus
•       AWS or cloud certifications
________________________________________
Key Skills
•       Clinical Data Standards: SDTM, ADaM, CDISC
•       Programming: SAS, Python, R, SQL
•       Cloud: AWS, Azure
•       Tools: Pinnacle 21, Git, Jenkins, Power BI, Grafana
•       Methodologies: Agile, DevOps, Data Governance