Senior Statistical Programmer – CDISC Lead
Core
Senior Statistical Programmer acting as a Subject Matter Expert (SME) and Project Manager for CDISC-compliant statistical programming, leading the preparation, execution, and documentation of regulatory submission data packages.
Role type
Senior IC Statistical Programmer (CDISC Lead)
Builds
Regulatory submission-ready data packages (SDTM, ADaM, Define.xml, TFLs) and internal CDISC programming infrastructure
Domain
Pharmaceutical/Biotechnology Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
CDISC standards governance (SDTM, ADaM), SAS programming, regulatory submission documentation (eCTD, SDRG, ADRG), project management, macro library development, quality control of clinical data
Preferred skills
R programming, Study Data Standardization Plan (SDSP) authoring, cross-study data integration (ISS/ISE), SEND standards, Agile/Scrum, management experience
Technologies
SAS, R, eCTD
Responsibilities
Lead development and review of CDISC-compliant dataset specifications; Perform QC of datasets and TFLs; Generate regulatory documentation; Optimize programming processes and templates; Provide technical support and training; Collaborate with statisticians and data management to resolve data issues; Validate/debug code from team members.
Seniority
Senior, hands-on IC with project leadership
