Statistical Programmer II
Tampa, FL · On-site
Performed CDISC Mapping for Ongoing clinical trials and classified data into domains. understanding with CDISC SDTM Implementation Guide v3.1.2/ v3.1.3 and SDTM Model. Proficient in generating ...
Tampa, FL · On-site
Performed CDISC Mapping for Ongoing clinical trials and classified data into domains. understanding with CDISC SDTM Implementation Guide v3.1.2/ v3.1.3 and SDTM Model. Proficient in generating ...
Tampa, FL · On-site
Performed CDISC Mapping for Ongoing clinical trials and classified data into domains. understanding with CDISC SDTM Implementation Guide v3.1.2/ v3.1.3 and SDTM Model. Proficient in generating ...
A CDISC SDTM specialist is a key team member on CDISC submission topics; provide industry leading CDISC expertise and programming leadership. They contribute to process improvements and initiatives ...
A CDISC SDTM specialist is a key team member on CDISC submission topics; provide industry leading CDISC expertise and programming leadership. They contribute to process improvements and initiatives ...
Fairfield, CT · On-site +1
The ideal candidate has strong expertise in CDISC standards, SDTM dataset development, and modern programming tools including SAS and R. This role partners closely with cross-functional teams to ...
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Fairfield, CT · On-site +1
The ideal candidate has strong expertise in CDISC standards, SDTM dataset development, and modern programming tools including SAS and R. This role partners closely with cross-functional teams to ...
Fairfield, CT · On-site +1
The ideal candidate has strong expertise in CDISC standards, SDTM dataset development, and modern programming tools including SAS and R. This role partners closely with cross-functional teams to ...
Fairfield, CT · On-site +1
The ideal candidate has strong expertise in CDISC standards, SDTM dataset development, and modern programming tools including SAS and R. This role partners closely with cross-functional teams to ...
Somerset, NJ · Remote
$110K - $120K/yr
Have good knowledge of pharmaceutical industry data standards such as CDISC SDTM and ADaM and produce the derived analysis datasets to meet these data standards * Have in depth understanding of ...
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Somerset, NJ · Remote
$110K - $120K/yr
Have good knowledge of pharmaceutical industry data standards such as CDISC SDTM and ADaM and produce the derived analysis datasets to meet these data standards * Have in depth understanding of ...
Somerset, NJ · Remote
$110K - $120K/yr
Have good knowledge of pharmaceutical industry data standards such as CDISC SDTM and ADaM and produce the derived analysis datasets to meet these data standards * Have in depth understanding of ...
Quick apply
Somerset, NJ · Remote
$110K - $120K/yr
Have good knowledge of pharmaceutical industry data standards such as CDISC SDTM and ADaM and produce the derived analysis datasets to meet these data standards * Have in depth understanding of ...
Perform validation of CDISC SDTM data in accordance with SOPs and guidance documents; * Ensure SDTM data conforms to the data standards expected by regulatory agencies; * Assist with creation of the ...
Perform validation of CDISC SDTM data in accordance with SOPs and guidance documents; * Ensure SDTM data conforms to the data standards expected by regulatory agencies; * Assist with creation of the ...
Perform validation of CDISC SDTM data in accordance with SOPs and guidance documents; * Ensure SDTM data conforms to the data standards expected by regulatory agencies; * Assist with creation of the ...
Perform validation of CDISC SDTM data in accordance with SOPs and guidance documents; * Ensure SDTM data conforms to the data standards expected by regulatory agencies; * Assist with creation of the ...
Upper Gwynedd, PA · On-site
$50 - $55/hr
Strong knowledge of SDTM. * Extensive programming experience in a clinical trial environment (CRO ... In-depth knowledge of CDISC standards and regulatory submission requirements. Responsibilities:
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Upper Gwynedd, PA · On-site
$50 - $55/hr
Strong knowledge of SDTM. * Extensive programming experience in a clinical trial environment (CRO ... In-depth knowledge of CDISC standards and regulatory submission requirements. Responsibilities:
Frederick, MD · On-site
$135K - $148K/yr
Extensive experience with CDISC, SDTM, and ADaM standards. * Experience supporting FDA submissions. * Strong knowledge of validation practices and regulatory requirements Venesco, LLC, is an equal ...
New
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Frederick, MD · On-site
$135K - $148K/yr
Extensive experience with CDISC, SDTM, and ADaM standards. * Experience supporting FDA submissions. * Strong knowledge of validation practices and regulatory requirements Venesco, LLC, is an equal ...
New
Alameda, CA · On-site
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 ...
Alameda, CA · On-site
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 ...
Develop, program, and validate CDISC SDTM datasets from raw clinical data (e.g., demographics, adverse events, labs, vitals, concomitant medications). * Develop, program, and validate CDISC ADaM ...
Develop, program, and validate CDISC SDTM datasets from raw clinical data (e.g., demographics, adverse events, labs, vitals, concomitant medications). * Develop, program, and validate CDISC ADaM ...
Develop programs to create SDTM datasets and Define.xml for statistical analysis, tables & listings, and regulatory submissions. * Perform Open CDISC validation, coordinate to resolve issues, prepare ...
Develop programs to create SDTM datasets and Define.xml for statistical analysis, tables & listings, and regulatory submissions. * Perform Open CDISC validation, coordinate to resolve issues, prepare ...
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 ...
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 ...
Boston, MA · On-site
... CDISC SDTM dataset delivery to Statistical Programmers or regulatory agencies • Engages appropriate stakeholders in communication to analyze user requirements, systems problems, and enhancements to ...
Boston, MA · On-site
... CDISC SDTM dataset delivery to Statistical Programmers or regulatory agencies • Engages appropriate stakeholders in communication to analyze user requirements, systems problems, and enhancements to ...
Develop, program, and validate CDISC SDTM datasets from raw clinical data (e.g., demographics, adverse events, labs, vitals, concomitant medications). * Develop, program, and validate CDISC ADaM ...
Develop, program, and validate CDISC SDTM datasets from raw clinical data (e.g., demographics, adverse events, labs, vitals, concomitant medications). * Develop, program, and validate CDISC ADaM ...
... 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 ...
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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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 ...
... conformance to CDISC standards and industry best practices as well as pipeline based SDTM ... development. This role implements the strategy and framework for governance of standards as set by ...
... conformance to CDISC standards and industry best practices as well as pipeline based SDTM ... development. This role implements the strategy and framework for governance of standards as set by ...
Experience with submission standards CDISC (SDTM, ADaM), Define.XML, SDRG, 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, SDRG, ADRG * Demonstrated success in the assurance of deliverable quality and process compliance. * Excels in technical writing ...
$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
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.
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.
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.

Full-time
Posted 9 days ago
Sourced by ZipRecruiter
Software development
11 - 50 Employees
Tampa, FL, US