Associate Director, Clinical Data Scientist

Overview

Associate Director, Clinical Data Scientist to lead clinical data science and advanced analytics that translate complex clinical, biomarker, and external data into evidence for clinical development decisions.

What you'll do

• Lead clinical data science strategy and delivery for one or more studies, assets, or capability areas.
• Drive statistical and advanced analytics (exploratory analysis, predictive modeling, simulation, integrated data review).
• Apply statistical and machine learning methods to support patient-level prediction, endpoint interpretation, risk assessment, and scenario planning.
• Define requirements for model-ready datasets and analytics-ready data flows, including lineage, traceability, metadata, and documentation.
• Partner cross-functionally to ensure high-quality, traceable analyses and submission-ready insights.
• Provide oversight of internal/external delivery partners, reviewing analysis plans, specs, code, outputs, and interpretations.

What you'll need

• PhD in a relevant field with 5+ years of relevant experience, or MS with 8+ years.
• Significant experience in clinical development in pharmaceutical/biotech/healthcare research environments.
• Experience with technical leadership, matrix leadership, vendor oversight, and/or mentorship.
• Advanced knowledge of clinical trial design, drug development, endpoints/estimands, and biomarkers.
• Hands-on proficiency in R and/or Python, with working knowledge of SAS and SQL.
• Working knowledge of CDISC standards including SDTM and ADaM.
• Knowledge of FDA, EMA, ICH-GCP, GxP, data privacy, and inspection readiness/traceability expectations.