... CDISC SDTM dataset delivery to Statistical Programmers or regulatory agencies Engages appropriate stakeholders in communication to analyze user requirements, systems problems, and enhancements to ...
... CDISC SDTM dataset delivery to Statistical Programmers or regulatory agencies Engages appropriate stakeholders in communication to analyze user requirements, systems problems, and enhancements to ...
Experience with submission standards CDISC (SDTM, ADaM), Define.XML, cSDRG, ADRG * Demonstrated success in the assurance of deliverable quality and process compliance. * Excels in technical writing ...
Experience with submission standards CDISC (SDTM, ADaM), Define.XML, cSDRG, ADRG * Demonstrated success in the assurance of deliverable quality and process compliance. * Excels in technical writing ...
Experience with submission standards CDISC (SDTM, ADaM), Define.XML, cSDRG, ADRG * Demonstrated success in the assurance of deliverable quality and process compliance. * Excels in technical writing ...
Experience with submission standards CDISC (SDTM, ADaM), Define.XML, cSDRG, ADRG * Demonstrated success in the assurance of deliverable quality and process compliance. * Excels in technical writing ...
Experience with submission standards CDISC (SDTM, ADaM), Define.XML, cSDRG, ADRG * Demonstrated success in the assurance of deliverable quality and process compliance. * Excels in technical writing ...
Experience with submission standards CDISC (SDTM, ADaM), Define.XML, cSDRG, ADRG * Demonstrated success in the assurance of deliverable quality and process compliance. * Excels in technical writing ...
Principal Biostatistician
Cambridge, MA · On-site
$178K - $216K/yr
Perform mapping from raw datasets to CDISC SDTM datasets * Produce and perform quality control of define.pdf, define.xml and annotated case report forms for SDTM submission * Develop SAS programs to ...
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Principal Biostatistician
Cambridge, MA · On-site
$178K - $216K/yr
Perform mapping from raw datasets to CDISC SDTM datasets * Produce and perform quality control of define.pdf, define.xml and annotated case report forms for SDTM submission * Develop SAS programs to ...
US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverablesExperience with submission standards CDISC (SDTM, ADaM ...
US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverablesExperience with submission standards CDISC (SDTM, ADaM ...
Clinical Data Manager
San Francisco, CA · Remote
$125K - $175K/yr
Collaborate with biostatistics on data standards (e.g., CDISC/SDTM) and analysis datasets * Ensure compliance with GCP, regulatory requirements, and company SOPs * Support inspection readiness and ...
Clinical Data Manager
San Francisco, CA · Remote
$125K - $175K/yr
Collaborate with biostatistics on data standards (e.g., CDISC/SDTM) and analysis datasets * Ensure compliance with GCP, regulatory requirements, and company SOPs * Support inspection readiness and ...
Clinical Data Manager
San Francisco, CA · On-site
$125K - $175K/yr
Collaborate with biostatistics on data standards (e.g., CDISC/SDTM) and analysis datasets * Ensure compliance with GCP, regulatory requirements, and company SOPs * Support inspection readiness and ...
Clinical Data Manager
San Francisco, CA · On-site
$125K - $175K/yr
Collaborate with biostatistics on data standards (e.g., CDISC/SDTM) and analysis datasets * Ensure compliance with GCP, regulatory requirements, and company SOPs * Support inspection readiness and ...
... from SDTM through ADaM to TLF generation in compliance with CDISC standards and regulatory requirements Develop SDTM CRF annotations and SDTM specifications, as well as analysis dataset ...
... from SDTM through ADaM to TLF generation in compliance with CDISC standards and regulatory requirements Develop SDTM CRF annotations and SDTM specifications, as well as analysis dataset ...
... from SDTM through ADaM to TLF generation in compliance with CDISC standards and regulatory requirements Develop SDTM CRF annotations and SDTM specifications, as well as analysis dataset ...
... from SDTM through ADaM to TLF generation in compliance with CDISC standards and regulatory requirements Develop SDTM CRF annotations and SDTM specifications, as well as analysis dataset ...
Senior EDC Programmer
Bothell, WA · On-site
$115K - $150K/yr
Collaborate with Data Management to ensure alignment with data standards (CDISC, SDTM where applicable). * Perform User Acceptance Testing (UAT) and support database releases and migrations. * Ensure ...
Senior EDC Programmer
Bothell, WA · On-site
$115K - $150K/yr
Collaborate with Data Management to ensure alignment with data standards (CDISC, SDTM where applicable). * Perform User Acceptance Testing (UAT) and support database releases and migrations. * Ensure ...
Sr Business Analyst with Life Sciences at Raleigh, NC (On-site)
Raleigh, NC · On-site
$89K - $116K/yr
Future-Ready Skills - Exposure to CDISC/SDTM/ADaM standards, OMOP mapping, and advanced analytics (R, Python, SAS). Familiarity with AI-driven accelerators (WinAIDM) for metadata-driven pipeline ...
Sr Business Analyst with Life Sciences at Raleigh, NC (On-site)
Raleigh, NC · On-site
$89K - $116K/yr
Future-Ready Skills - Exposure to CDISC/SDTM/ADaM standards, OMOP mapping, and advanced analytics (R, Python, SAS). Familiarity with AI-driven accelerators (WinAIDM) for metadata-driven pipeline ...
Knowledge of industry standards (CDISC, SDTM, CDASH). * Working knowledge of statistical programming packages (e.g. SAS) is a plus. #LI-Hybrid #LI-JC1
Knowledge of industry standards (CDISC, SDTM, CDASH). * Working knowledge of statistical programming packages (e.g. SAS) is a plus. #LI-Hybrid #LI-JC1
Hands-on knowledge of CDISC SDTM and ADaM models and transforming raw data into these standards. * In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of ...
Hands-on knowledge of CDISC SDTM and ADaM models and transforming raw data into these standards. * In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of ...
Develops Study Data Tabulation Models (SDTMs) and Arrangement of variables (ADaM) mapping specifications in accordance with CDISC SDTM Implementation Guides (SDTM IG). * Programs and validates SDTM ...
Develops Study Data Tabulation Models (SDTMs) and Arrangement of variables (ADaM) mapping specifications in accordance with CDISC SDTM Implementation Guides (SDTM IG). * Programs and validates SDTM ...
Director, Clinical Reporting
Pottstown, PA · Remote
$81K - $111K/yr
Working knowledge of CDISC, SDTM, and ADaM; * Expert knowledge of SAS-based statistical programming and Statistical Computing Environments (SCEs); * 15 plus years Pharmaceutical or CRO industry ...
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Director, Clinical Reporting
Pottstown, PA · Remote
$81K - $111K/yr
Working knowledge of CDISC, SDTM, and ADaM; * Expert knowledge of SAS-based statistical programming and Statistical Computing Environments (SCEs); * 15 plus years Pharmaceutical or CRO industry ...
Senior Statistician
$89K - $109K/yr
Working knowledge of CDISC, SDTM and ADaM * Minimum 2 years' technical project management experience directing statisticians and statistical programmers * Experience in developing, writing ...
Senior Statistician
$89K - $109K/yr
Working knowledge of CDISC, SDTM and ADaM * Minimum 2 years' technical project management experience directing statisticians and statistical programmers * Experience in developing, writing ...
Decision Analytics Associate Consultant - Biometrics
South San Francisco, CA · On-site
$117K - $133K/yr
Analyze current-state clinical data flows, systems, and standards (e.g., EDC platforms, non-EDC sources, CDISC SDTM, ADaM) and define future-state architectures and processes. * Design, specify, or ...
Decision Analytics Associate Consultant - Biometrics
South San Francisco, CA · On-site
$117K - $133K/yr
Analyze current-state clinical data flows, systems, and standards (e.g., EDC platforms, non-EDC sources, CDISC SDTM, ADaM) and define future-state architectures and processes. * Design, specify, or ...
Associate Director, Statistical Programming
Cambridge, MA · On-site +1
$180K - $210K/yr
Hands-on knowledge of CDISC SDTM and ADaM models and transforming raw data into these standards. * In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of ...
Associate Director, Statistical Programming
Cambridge, MA · On-site +1
$180K - $210K/yr
Hands-on knowledge of CDISC SDTM and ADaM models and transforming raw data into these standards. * In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of ...
Statistical Programming Associate Director
Marlborough, MA · On-site
$168K - $210K/yr
Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's Guide for Electronic Submission. * Perform Data analysis, statistical analysis, generate safety and efficacy tables ...
Statistical Programming Associate Director
Marlborough, MA · On-site
$168K - $210K/yr
Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's Guide for Electronic Submission. * Perform Data analysis, statistical analysis, generate safety and efficacy tables ...
Cdisc Sdtm information
See salary details
$19.23 - $24.78
4% of jobs
$24.78 - $30.33
9% of jobs
$30.33 - $35.88
4% of jobs
$35.88 - $41.43
7% of jobs
$41.78 is the 25th percentile. Wages below this are outliers.
$41.43 - $46.98
9% of jobs
The median wage is $52.53 / hr.
$46.98 - $52.53
17% of jobs
$52.53 - $58.09
7% of jobs
$58.09 - $63.64
14% of jobs
$65.40 is the 75th percentile. Wages above this are outliers.
$63.64 - $69.19
12% of jobs
$69.19 - $74.74
10% of jobs
$74.74 - $80.29
7% of jobs
$19
$54
$80
How much do cdisc sdtm jobs pay per hour?
What are the key skills and qualifications needed to thrive in the Cdisc Sdtm position, and why are they important?
To thrive as a CDISC SDTM specialist, you need a deep understanding of clinical data management, strong knowledge of CDISC standards (particularly SDTM), and experience with statistical programming languages such as SAS. Familiarity with industry tools like Pinnacle 21, Medidata Rave, and relevant CDISC certifications is highly valued. Attention to detail, analytical thinking, and effective communication skills help distinguish top performers in this role. These capabilities are crucial for ensuring the accurate, compliant, and efficient transformation of clinical trial data into standardized formats for regulatory submission.
What is a CDISC SDTM job?
A CDISC SDTM job involves working with clinical trial data to ensure it complies with the Study Data Tabulation Model (SDTM) standard set by the Clinical Data Interchange Standards Consortium (CDISC). Professionals in this role transform raw clinical data into standardized SDTM domains for regulatory submissions to agencies like the FDA. Responsibilities typically include data mapping, programming (using SAS), validation, and documentation. This role is crucial for ensuring data integrity, consistency, and compliance in clinical research.
What does a typical day look like for a CDISC SDTM specialist?
A typical day as a CDISC SDTM specialist involves mapping raw clinical trial data to SDTM standards, collaborating closely with data managers, biostatisticians, and clinical programmers to resolve data issues, and validating data sets for consistency and compliance. You may also participate in meetings to discuss project progress, handle quality control checks using specialized software, and prepare documentation for regulatory submissions. The role often requires balancing independent programming work with teamwork across various functions in a dynamic, deadline-driven environment. This diverse set of tasks provides an engaging workday for those who enjoy both problem-solving and cross-functional collaboration.

Contractor
Posted 15 days ago
Job description
Our company is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. Founded in MA. Our company today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For four years in a row, Science magazine has named our company one of its Top Employers in the life sciences.
This position is responsible for overseeing and leading in the specification, production and QC of non-statistical clinical reports. This position oversees staff and works actively with key stakeholders, including Data Management and GPS, to understand requirements for non-statistical clinical reporting and implement these reports with high quality and on time. This position is responsible for taking a lead role in SAS programming support of centralized specification, production and QC of SDTM datasets for use by Statistical Programming and others, and in preparation for submission to regulatory agencies. This position serves as a highly skilled advisor to ensure high quality and proper conduct in support of above responsibilities.
Key Responsibilities:
Oversees and leads in specification, programming, and QC of SAS programs in support of non-statistical reporting business needs, specifically for DM but also other company departments such as Global Patient Safety
Oversees and leads in specification, programming, and QC of SAS programs in support of CDISC SDTM dataset delivery to Statistical Programmers or regulatory agencies
Engages appropriate stakeholders in communication to analyze user requirements, systems problems, and enhancements to current system's capabilities
Oversees team of programmers to implement non-statistical reports to support user needs related to raw clinical trials data , typically in SAS
Leads in vendor relationships, timelines, and technical functions related to specification, programming, and QC of non-statistical clinical reports and SDTM datasets
Leads activities across project boundaries when appropriate and integrates activities with those of other groups and departments as needed
Analyzes and communicates assessment of resources and utilization of resources to support business needs
May supervise staff engaged in these activities
Performs other duties as assigned
Master's degree and 8+ years of statistical programming experience, or
Bachelor's degree and 10+ years of statistical programming experience
Preferred Qualifications:
Possesses expert knowledge in SAS programming and can mentor, train, develop clinical programmers in using SAS to perform complex data handling and non-statistical clinical data reporting
Possesses hands-on knowledge of clinical trials lifecycle from data collection through production of statistical reports
Expert in hands-on knowledge of DM clinical reporting needs
Expert in hands-on knowledge of the CDISC SDTM model
Possesses knowledge of regulatory requirements for clinical trials data handling and reporting
Exhibits proficiency in tasks and skills including teamwork, planning, organization, delegation, coordination, and oversight of vendors
Demonstrates a record of operational and ethical standards, and team improvement
Exhibits strong communication skills with ability to impact and influence the decisions of a team
Demonstrates innovation and creativity in aligning technology with and driving business objectives
Strong communicator and able to present ideas, engage in dialogue with persons in a variety of other functions, especially Statistical Programmers, Biostatisticians, Data Management, and other departments engaged in providing data for SDTM packages or using non-statistical clinical reports
All your information will be kept confidential according to EEO guidelines.
About Lenox Executive Search
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
11 - 50 Employees
Headquarters location
Wellfleet, MA, US
Year founded
1991