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Cdisc Sdtm Adam Jobs (NOW HIRING)

Senior Clinical Programmer

Palo Alto, CA · On-site

$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 ...

Uphold industry standards including protocol compliance, ICH GCP, FDA regulations, and CDISC standards (SDTM, ADaM). Qualifications: * Bachelor's degree in Biostatistics, Computer Science, Life ...

Execute data cleaning, transformation, and standardization tasks across clinical datasets from EDC, vendor and real-world data sources, aligning outputs with CDISC (SDTM/ADaM) standards. * Develop ...

Execute data cleaning, transformation, and standardization tasks across clinical datasets from EDC, vendor and real-world data sources, aligning outputs with CDISC (SDTM/ADaM) standards. * Develop ...

Ensure compliance with CDISC standards (SDTM/ADaM) and FDA/ICH guidelines. Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading staffing and recruiting ...

Strong, handson experience with CDISC SDTM, ADaM and TLFs . * Proven experience developing safety, PK, and PK/PD ADaM datasets . * Experience supporting POPPK/popPD/Exposure Response(ER) dataset ...

A CDISC SDTM specialist is a key team member on CDISC submission topics; provide industry leading ... STDM/ADaM, and e-submissions). Communicate with regulatory agencies regarding electronic data ...

Statistical Programmer

Redmond, WA · On-site

$80K - $100K/yr

Working knowledge of CDISC standards (SDTM and ADaM). * Hands-on experience in developing and validating SDTM and ADaM datasets, as well as statistical outputs (tables, figures, and listings)

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How much do cdisc sdtm adam jobs pay per hour?

As of Jul 15, 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.
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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.

Senior Manager, Statistical Programming

Kardigan

South San Francisco, CA • On-site

Other

Re-posted 19 days ago


Job description

Position Title: Senior Manager, Statistical Programming

Department: Clinical Data Sciences & Analytics 

Reports To: Head of Statistical Programming

Location: South San Francisco, CA or Princeton, NJ - On-site 4 days per week (Mon to Thurs) 

Job Overview:

The Senior Manager of Statistical Programming will be responsible for leading Statistical Programming activities. It involves hands-on implementation of statistical analyses using SAS/R, as well as performing quality reviews of deliverables, both for in-house analyses and outsourced programming tasks.

This position serves as a critical bridge between Biostatistics and Clinical Data Management (CDM), ensuring the development of CRFs and the delivery of high-quality clinical data. Additionally, this position will play an important role in helping establish SOPs and programming standards and also build our SCE platform.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Key Project Responsibilities:

  • Provides programming leadership and oversee study to compound-level programming deliverable in collaboration with the Stats lead and cross-functional teams.
  • Serve as the lead programmer to reviews SAP, Data Presentation Plan, Table Shell to align with project objectives and ensures clarity and completeness of programming assumptions and requirements.
  • Lead programming team to produce and/or validate SDTM, ADaM and TLF, for CSR and regulatory requests, publication needs, and ad-hoc analyses.
  • Manage CROs and contractors, ensuring compliance, quality of deliverables, timelines, and budget adherence.
  • Collaborate with biostatisticians and clinical development colleagues to develop/review TLF shells, SDTM, and ADaM specifications.
  • Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports.
  • Develop global tools, such as macros or graphical user interface applications, to enhance the efficiency and capacity of the Statistical Programming team.
  • Develops robust program to create define.xml, Leads the NDA eSubmission package preparation.
  • Assist Biometric in building the statistical computing environment (SCE) platform, including designing folder structure and managing access control.

Initiative Responsibilities:

  • Under guidance from Head of Statistical Programming and Compound PL, implement innovative strategies and technologies to enhance programming processes.
  • Working with manager, establish Statistical Programming standard and deploy programming strategies, specifications and programmed analysis.
  • Proactively plan, implement, and identify issues/risks and provide remediation strategies to improve programming capability.

Qualifications and Preferred Skills

Education:

  • Master's degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field.

Experience and Skill Set:

  • Minimum of 6 years statistical programming experience in the pharmaceutical, biotech or CRO clinical trial environment.
  • Advanced SAS programming skills. Extensive Hands-on experience with SDTM, ADaM, TLF programming
  • Proficient knowledge in the implementation of CDISC standards (SDTM, ADaM) and regulatory submission requirements.
  • Good knowledge of drug development process, study design, statistical methodology, regulatory guidance, statistical concepts, and medical terminology.
  • Broad expertise in statistical programming and in developing computing strategies.
  • In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of their implementation in clinical trials.
  • Demonstrated proficiency in using SAS/R to produce analysis datasets and TFLs.
  • Knowledge of data validation, define.xml generation using Pinnacle 21.
  • Results orientated with proven problem-solving skills and a strong interest in ongoing learning.
  • Excellent communication and collaboration skills, with the ability to work closely with cross-functional teams
  • Experience managing outsourced programming activities and overseeing deliverables from CROs and contractors.
  • Adaptable and thrives in a fast-paced, startup environment while managing multiple priorities effectively.
  • Experience with regulatory audits and inspections and IR (e.g., FDA, PMDA, NMPA, EMA) is a strong advantage.