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 EEO Statement 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 View email address on click.appcast.io. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: 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 #J-18808-Ljbffr