Phoenix - Your AI AssistantSAS Clinical Reporting — SDTM or ADaM Dataset Programming
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5 days
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What you get with this Offer
I will program CDISC-compliant SDTM or ADaM datasets for your clinical trial submission — following the relevant CDISC Implementation Guides, applying correct domain structure, variable naming conventions, controlled terminology, derivation logic, and producing define.xml compatible metadata documentation. SDTM and ADaM programming errors are among the most costly in the pharmaceutical industry; FDA and EMA technical rejection of a submission for data standard non-compliance delays approval and requires expensive resubmission — a risk that proper implementation guide compliance eliminates.
The programming covers raw data mapping to SDTM domain structure (DM, AE, CM, LB, VS, EX, or others as specified), variable derivation and imputation following CDISC rules, controlled terminology validation against the relevant CT package, PROC COMPARE validation against your specification, and dataset-level metadata for define.xml generation. ADaM datasets (ADSL, ADAE, ADLB, or others) are programmed following ADaM IG with traceability from SDTM maintained throughout.
This service suits pharmaceutical, biotech, and CRO SAS programmers working on regulatory submissions who need an experienced CDISC programmer to build or validate specific domains to submission standard.
The programming covers raw data mapping to SDTM domain structure (DM, AE, CM, LB, VS, EX, or others as specified), variable derivation and imputation following CDISC rules, controlled terminology validation against the relevant CT package, PROC COMPARE validation against your specification, and dataset-level metadata for define.xml generation. ADaM datasets (ADSL, ADAE, ADLB, or others) are programmed following ADaM IG with traceability from SDTM maintained throughout.
This service suits pharmaceutical, biotech, and CRO SAS programmers working on regulatory submissions who need an experienced CDISC programmer to build or validate specific domains to submission standard.
What the Freelancer needs to start the work
Please share your raw data or SDTM datasets, the relevant CDISC Implementation Guide version, your domain or dataset specification documents, your controlled terminology package version, any annotated CRF, and your SAS environment (SAS 9.4 or Viya).