Senior Manager, Technical SME Standards
New
United StatesFull-TimeManager
SalaryApproximately $153,935 to $219,120
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Job Details
- Experience
- 8+ years of experience with a BS; 4+ years with an MS; 2+ years with a PhD
- Required Skills
- PythonGCPRGitHub
Requirements
- 8+ years of experience with a BS degree, 4+ years with an MS, or 2+ years with a PhD in Biostatistics, Computer Science, or related field.
- Strong experience in clinical trials across multiple phases and therapeutic areas.
- Deep understanding of CDISC standards (SDTM/ADaM), FDA and ICH guidelines, and GCP.
- Experience with clinical data pipelines, metadata management, and end-to-end data workflows in regulated environments.
- Proficiency in programming languages such as R or Python.
- Exposure to AI-assisted development and modern software engineering practices.
- Experience collaborating in cross-functional teams using GitHub or similar development environments.
- Strong analytical, problem-solving, and stakeholder management skills.
Responsibilities
- Serve as a technical liaison between Data Standards, Clinical Data Engineering, and IT teams to ensure alignment on automation initiatives.
- Design and implement tools for data lineage, impact assessments, and traceability from collection to reporting.
- Develop automation solutions for SDTM and ADaM dataset generation and integration.
- Oversee data standards platform operations, including configuration, access management, and governance.
- Document and test analytical and automation tools supporting statistical outputs and submission datasets.
- Champion digital data flow strategies to increase efficiency and data quality in clinical trials.
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