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Cdisc Sdtm Adam Jobs in Raleigh, NC (NOW HIRING)

micro1 AI

Biostatistician

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

Biostatistician

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

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

Biostatistician

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 ...

IQVIA

Principal Statistical Programmer

Durham, NC · On-site

$98K - $273K/yr

SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...

IQVIA

Principal Statistical Programmer

Durham, NC

$98K - $273K/yr

SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...

IQVIA, Inc.

Principal Statistical Programmer

Durham, NC · On-site

$98K - $273K/yr

SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...

LivaNova

Statistical Programmer II

Raleigh, NC

$90K - $100K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Working knowledge of CDISC standards, especially SDTM and ADaM. * Ability to support dataset creation, validation, listings, tables, figures, and ad hoc analyses. * Understanding of clinical trial ...

Gilead

Senior Manager, Statistical Programming

Raleigh, NC

$169K - $219K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • PTO

Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM) * Proven experience in complex and fast turnaround programming activities * Excellent interpersonal, communication, problem solving, and ...

WiTH Collective

Senior Statistical Programmer (Remote)

Cary, NC · On-site

$104.75 - $128/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Develop, validate, and document SAS programs for clinical trial datasets (SDTM, ADaM) and outputs ... In depth knowledge of CDISC requirements required. * Understanding of Statistical Analysis Plan ...

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Cdisc Sdtm Adam information

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How much do cdisc sdtm adam jobs pay per hour?

As of Aug 19, 2026, the average hourly pay for cdisc sdtm adam in Raleigh, NC is $52.67, according to ZipRecruiter salary data. Most workers in this role earn between $33.41 and $79.23 per hour, depending on experience, location, and employer.

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 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 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 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.

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Cdisc Sdtm Adam jobs near you

Statistical Programmer / Clinical Data Architect

Volto USA

Raleigh, NC • On-site

Contractor

Re-posted 17 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