Responsibilities
- Develop and deliver data science analyses supporting clinical development, regulatory submissions, publications, and exploratory analyses.
- Partner with Biostatistics on innovative analyses (e.g., simulations, external controls, RWE integration, ML/GenAI predictive analytics).
- Ensure alignment between exploratory analytics and CDISC-based submission deliverables; maintain inspection-ready documentation.
- Support analysis of emerging data types (biomarkers, digital endpoints, RWD, text, imaging) with interpretability and quality.
- Contribute to responses to regulatory queries and preparation of advanced-analytics submission materials.
- Build and maintain analysis workflows using SAS and/or R/Python, balancing innovation with compliance.
- Create reusable tools, macros, templates, and pipelines to improve efficiency, reproducibility, and scalability.
- Contribute to reproducible pipelines (version control, data engineering, automation).
- Support dashboards/visualizations (e.g., Shiny, Plotly).
- Improve study execution and operational insights (e.g., enrollment trends, data quality signals, feasibility).
- Collaborate with Biostatistics, Data Management, Clinical Operations, and CRO partners; review SAPs/CRFs/DMPs/database specs for alignment.
- Translate outputs into actionable insights for technical and non-technical audiences.
Qualifications & Skills
- Strong experience in SAS, R, or Python for analysis/visualization.
- Data science methods: ML model development lifecycle; GenAI/agentic AI is a plus.
- Experience with clinical development and regulatory submissions (pharma/biotech or CRO).
- Hands-on experience with CDISC (SDTM, ADaM) and integration with exploratory analytics.
- Experience with diverse data types and data engineering pipeline development.
- Reproducible research practices (version control, structured workflows).
- Ability to analyze complex datasets and communicate insights.
- Detail-oriented; strong quality/accuracy.
- Autoimmune/immunology therapeutic experience is a plus.
Associate Director only (preferred)
- Experience influencing program-level strategy; cross-functional alignment; mentoring and CRO/vendor oversight.
- Exposure to advanced analytics in regulated environments (causal inference, simulations, RWE).
Education & Experience
- Senior Manager: BS (8+ years) or MS (6+ years).
- Associate Director: BS (10+ years) or MS (8+ years).