Senior Statistical Programmer, CDISC SDTM/ADaM

Jobtailor; New Jersey; On-site; USD 110,000 - 150,000; Full time

Job summary

Jobtailor is seeking an experienced SAS programmer to support clinical studies in the United States. You will perform statistical programming compliant with CDISC standards (SDTM/ADaM), produce CDISC deliverables, and execute statistical analyses.

You will collaborate with biostatisticians on study design, write SAPs, and validate regulatory submission deliverables. A Master's degree or PhD in biostatistics or related field is required, with 6–8 years of SAS experience and Pinnacle 21

Qualifications

• 6-8 years in SAS.
• SDTM/ADaM QA experience.
• Regulatory submissions experience (Pinnacle 21).
• Master's degree (MSc) or PhD in Biostatistics, Statistics, Mathematics, or related field.
• Proficiency in SAS (Base SAS, SAS Studio, SAS Viya).
• Strong expertise in CDISC SDTM and ADaM standards.
• Knowledge of TLFs (Tables, Listings, and Figures) and regulatory requirements.
• Experience using Pinnacle 21.
• Fluent English (written and spoken).

Responsibilities

• Support clinical studies through statistical programming compliant with CDISC standards (SDTM/ADaM).
• Produce, validate, and review CDISC deliverables.
• Execute and support statistical analyses.
• Collaborate with biostatisticians in study design.
• Write and review Statistical Analysis Plans (SAPs).
• Validate regulatory submission deliverables.

Skills

SAS Programming

CDISC SDTM

CDISC ADaM

Regulatory Submissions

Pinnacle 21

SAS Studio

SAS Viya

Education

Master's Degree (MSc) or PhD in Biostatistics/Statistics/Mathematics

Tools

SAS

SAS Studio

SAS Viya

Job description

• Support clinical studies through statistical programming compliant with CDISC standards (SDTM/ADaM)
• Produce, validate, and review CDISC deliverables
• Execute and support statistical analyses
• Collaborate with biostatisticians in study design
• Write and review Statistical Analysis Plans (SAPs)
• Validate regulatory submission deliverables

Requirements

• 6-8 years in SAS
• SDTM/ADaM QA
• Regulatory submissions (Pinnacle 21)
• Master's degree (MSc) or PhD in Biostatistics, Statistics, Mathematics, or a related field
• Proficiency in SAS (Base SAS, SAS Studio, SAS Viya)
• Strong expertise in CDISC SDTM and ADaM standards
• Knowledge of TLFs (Tables, Listings, and Figures) and regulatory requirements
• Experience using Pinnacle 21
• Fluent English (written and spoken)

Core Competencies

Demonstrates expertise in statistical programming and analysis, particularly in SAS, while ensuring compliance with CDISC standards for clinical studies. Proficient in producing and validating regulatory submission deliverables and collaborating effectively with biostatisticians.

Highest-signal resume keywords

• SAS Programming
• CDISC SDTM Standards
• CDISC ADaM Standards
• Regulatory Submissions
• Pinnacle 21

ATS Optimization Keywords

Hard Skills

• SAS
• Statistical Analysis
• Statistical Programming
• CDISC Deliverables
• Statistical Analysis Plans
• SDTM/ADaM QA
• TLFs (Tables, Listings, Figures)
• Regulatory Requirements
• SAS Studio
• SAS Viya

Certifications & Qualifications

• Master's Degree (MSc) or PhD in Biostatistics, Statistics, Mathematics

Industry Keywords

• Clinical Studies
• Biostatistics
• Regulatory Compliance
• Statistical Programming Standards