Senior Clinical Statistical Programmer

Job Description Data Standards & Harmonization

• Lead end-to-end mapping and transformation of SDTM domains
• Ensure compliance with: ○

CDISC SDTM

standards ○ Sponsor-specific controlled terminology and structure

• Perform consistency checks against previously harmonized datasets
• Support harmonized datasets for integrated analysis readiness ADaM Dataset Creation
• Develop ADaM datasets (using Admiral R package) based on: ○ Statistical Analysis Plan (SAP) ○ Analysis specifications
• Ensure traceability between SDTM and ADaM

Implement:

○ Derived variables ○ Population flags ○ Analysis endpoints Regulatory-Ready Documentation & Deliverables Prepare submission-ready outputs aligned with FDA/EMA expectations, including:

• SDTM & ADaM datasets (with define.xml)
• Dataset-level and analysis-level documentation
• Example outputs and sample displays
• Integrated Case Report Forms (iCRFs)
• Reviewer documentation: ○ Clinical Study Reviewer's Guide (cSDRG) ○ ADaM Reviewer's Guide (aDRG)
• Variable derivation documentation and codelist mappings
• Annotated CRFs SAS Programming & Integrated Outputs
• Write production-level SAS programs, including: ○ Source-to-target mapping macros/scripts ○ Validation checks ○ Reusable code modules
• Create integrated clinical study reports
• Produce Integrated Clinical Study DRG (iCSDRG) documentation
• Populate iSDRGs from SAS outputs

Ensure:

○ Independent review readiness ○ Good programming practices (GPP) ○ Data quality and reproducibility Quality Control & Collaboration

• Perform QC/validation using Pinnacle 21 on: ○ Harmonized Sponsor Study SDTMs ○ Overall Harmonized SDTMs
• Resolve validation discrepancies across studies
• Partner cross-functionally to: ○ Address data issues ○ Clarify specifications

Maintain:

○ Detailed documentation ○ Version control ○ Audit trails

• Participate in regular project check-ins We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.

We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements Key Standards & Tools

• CDISC standards: SDTM, ADaM
• SAS (incl. SAS Macro language)
• Pinnacle 21
• Regulatory focus: FDA/EMA submissions
• Common acronyms: ○ ADaM = Analysis Data Model ○ SDTM = Study Data Tabulation Model ○ CDISC = Clinical Data Interchange Standards Consortium