ZipRecruiter

Log In

1

Cdisc Sdtm Adam Jobs (NOW HIRING)

Navitas Life Sciences

Senior Statistical Programmer

Working knowledge of CDISC, SDTM and ADaM * Expert knowledge of SAS-based statistical programming * Proficiency in SAS programming on multiple platforms and operating systems, e.g. Windows, UNIX, etc ...

Recor Medical

Senior Clinical Programmer

Palo Alto, CA

$145K - $156K/yr

Establish and enforce data standardization practices (e.g., CDISC, SDTM, ADaM) * Collaborate with cross-functional teams including clinical operations, biostatistics, and regulatory affairs * Assess ...

next page

Showing results 1-20

All JobsCdisc Sdtm Adam Jobs

Cdisc Sdtm Adam information

See salary details

$16

$54

$89

How much do cdisc sdtm adam jobs pay per hour?

As of Jul 13, 2026, the average hourly pay for cdisc sdtm adam in the United States is $54.18, according to ZipRecruiter salary data. Most workers in this role earn between $34.38 and $81.49 per hour, depending on experience, location, and employer.

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.

What is the difference between ADaM and SDTM?

In the context of a Cdisc Sdtm Adam role, SDTM (Study Data Tabulation Model) is a standardized format for organizing and submitting clinical trial data, while ADaM (Analysis Data Model) is used to create analysis datasets that support statistical analysis. SDTM provides the raw data structure, and ADaM datasets are derived from SDTM to facilitate analysis and reporting. Both require knowledge of CDISC standards and data management skills.

What is ADaM in SAS?

In the context of a Cdisc Sdtm Adam role, ADaM (Analysis Data Model) in SAS refers to a set of standards and data structures used to create analysis datasets for clinical trials. It ensures consistency and traceability of data used in statistical analyses, often requiring knowledge of SAS programming and CDISC guidelines. ADaM datasets are essential for regulatory submissions and accurate data analysis.

Is CDISC required by FDA?

For a Cdisc Sdtm Adam role, understanding that the FDA recommends the use of CDISC standards, including SDTM, for clinical trial data submission is essential. While not legally mandated, compliance with CDISC standards is strongly encouraged to facilitate regulatory review and approval processes.

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 cdisc, SDTM, and ADaM?

Cdisc is an organization that develops standards for clinical trial data, including SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model). SDTM organizes raw clinical data for submission, while ADaM prepares analysis datasets for statistical analysis. Professionals working as Cdisc SDTM ADaM specialists need knowledge of clinical data standards and data management tools.
More about Cdisc Sdtm Adam jobs
What cities are hiring for Cdisc Sdtm Adam jobs? Cities with the most Cdisc Sdtm Adam job openings:
What states have the most Cdisc Sdtm Adam jobs? States with the most job openings for Cdisc Sdtm Adam jobs include:
What job categories do people searching Cdisc Sdtm Adam jobs look for? The top searched job categories for Cdisc Sdtm Adam jobs are:
Cdisc Sdtm Adam jobs near you
Infographic showing various Cdisc Sdtm Adam job openings in the United States as of July 2026, with employment types broken down into 87% Full Time, 11% Part Time, 1% Temporary, and 1% Contract. Highlights an 84% Physical, and 16% Remote job distribution, with an average salary of $112,695 per year, or $54.2 per hour.
Clinical Data Management SME with Data Architectecture or Data Engineering Experience

Clinical Data Management SME with Data Architectecture or Data Engineering Experience

V.L.S. Systems, Inc

Alameda, CA • On-site

Other

Posted 17 days ago

Job description

Data Architect or Senior Data Engineer with experience in Clinical SDTM Data Management***

The SME should have strong experience working in clinical IT environments with a strong business-facing orientation, closely partnering with stakeholders across Biostatistics, Statistical Programming, Clinical Operations, and Clinical Data Management.

This role requires deep hands-on expertise in clinical data standards and regulatory submission datasets, with frequent collaboration with Biostatistics teams to ensure high-quality downstream analysis-ready data.

Key Responsibilities & Collaboration Areas

Work closely with Biostatistics teams to support study design, analysis readiness, and submission data strategy

Partner with Statistical Programmers to ensure correct implementation of analysis datasets

Collaborate with Clinical Data Managers (CDM) to ensure source data aligns with downstream SDTM requirements

Interface with Clinical Operations (Clin Ops) to ensure operational data capture supports analysis needs

Act as a bridge between IT systems/data architecture and clinical study execution teams

Core Technical Expertise Required

Strong expertise in CDISC standards, especially:

CDISC Standards

Deep knowledge of SDTM (Study Data Tabulation Model) including:

Domain structures and mapping from raw clinical data

Controlled terminology and implementation guidelines

Submission-ready SDTM datasets

Strong understanding of ADaM (Analysis Data Model):

Dataset creation for statistical analysis

Traceability from SDTM ? ADaM ? TLFs (Tables, Listings, Figures)

Experience with SDTM domain mapping specifications and transformation logic

Familiarity with regulatory submission expectations (e.g., FDA/PMDA)

Ideal Profile

Proven experience working in clinical trial data environments

Hands-on exposure to SDTM and ADaM dataset creation or review

Strong ability to translate between:

Clinical/business requirements

Statistical analysis needs

Technical data structures

Comfortable engaging in deep technical discussions with biostatisticians

Ability to act as a translation layer between IT/data systems and scientific teams

We are seeking a Senior Clinical Data Management SME to provide clinical data leadership across active studies. This role will own clinical data standards, study-level data management planning, data quality planning, SDTM/ADaM mapping oversight, CRO/vendor data onboarding, and translation of clinical study requirements into data pipeline specifications.

The role requires deep experience in clinical data management, CDISC standards, SDTM/ADaM, eCRF design, study protocols, data quality, vendor governance, and clinical data delivery.

________________________________________

Key Responsibilities

Serve as the primary Clinical Data Management SME across active clinical studies.

Own and maintain CDISC standards, Clinical Data Management Plans, and Data Quality Plans.

Own SDTM/ADaM mapping authority across studies and validate domain conformance.

Review and approve SDTM/ADaM mappings, data quality rules, and study artifacts before release to production.

Govern CRO and vendor data onboarding, including data transfer plans, SLAs, acceptance criteria, in-stream data flows, and exception handling.

Translate study protocols, eCRFs, and reporting/analysis plans into pipeline requirements for data engineering teams.

Partner with Clinical Operations, Biostatistics, Data Management, CROs, data engineers, and data managers.

Ensure study data is complete, accurate, traceable, standardized, and ready for downstream analysis.

Provide SME guidance to offshore engineers and data managers on clinical data standards, mappings, and study-specific requirements.

Support issue resolution related to clinical data quality, mapping gaps, transformation logic, and vendor data defects.

________________________________________

Required Qualifications

10+ years of experience in Clinical Data Management within pharma, biotech, or CRO environments.

Strong working knowledge of CDISC, SDTM, and ADaM standards.

Experience with:

o Clinical Data Management Plans

o Data Quality Plans

o Data Transfer Plans

o eCRF specifications

o SDTM/ADaM mapping specifications

o Edit checks and validation rules

o Clinical data review and reconciliation

Ability to interpret study protocols, eCRFs, CRF annotations, reporting plans, and analysis plans.

Experience managing or coordinating with CROs and third-party data vendors.

Strong understanding of clinical trial data lifecycle from data collection through analysis and submission readiness.

Ability to convert clinical requirements into clear technical specifications.

Strong communication and stakeholder management skills.

________________________________________

Preferred Qualifications

Experience with regulatory submission data packages.

Experience with EDC systems, clinical data repositories, clinical data hubs, or clinical data platforms.

Familiarity with metadata-driven pipelines, automation, or AI-assisted data mapping and rule generation.

Experience supporting oncology or specialty pharma studies.

Experience working with distributed onsite/offshore delivery teams.

Knowledge of data governance, lineage, auditability, and quality controls in clinical data environments.

________________________________________

Key Skills

Clinical Data Management, CDISC, SDTM, ADaM, eCRF, Study Protocols, Data Quality, Data Transfer Plans, CRO/Vendor Governance, Data Mapping, Clinical Data Standards, Edit Checks, Data Reconciliation, Regulatory Submission Readiness, Clinical Operations, Biostatistics, Data Engineering Collaboration.

Apply