Senior Lead Clinical Data Science Programmer
Core
Lead the development and management of Data Transfer Specifications (DTS) to align external data providers and research partners on data structures, formats, and templates for clinical studies.
Role type
Senior Lead Clinical Data Science Programmer
Builds
Data Transfer Specifications (DTS) and standardized external data pipelines
Domain
Clinical research, biotechnology, pharmaceutical
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Data Transfer Specification (DTS) authoring, CDISC standards compliance, external data management, regulatory compliance (21 CFR Part 11, ICH-GCP), database structure design, SAS/CSV/XML data extraction, vendor management
Preferred skills
Biomarker data handling, imaging data management, oncology study experience, non-oncology study experience
Technologies
SAS, CSV, XML
Responsibilities
Author and manage Data Transfer Specifications (DTS), ensure study teams adhere to CDISC standards, serve as primary contact for external data quality control, provide operational oversight to external data vendors, support data reconciliation and regulatory compliance
Seniority
Senior, hands-on IC
