Principal Clinical Data Scientist

Overview

As a Principal/Senior Clinical Scientist, you will lead the clinical science function across Oncology, Rare Diseases, and/or Autoimmune programs from start-up to database lock. You will apply indication-specific expertise to support data collection, review, and interpretation within a cross-functional data review team, ensuring high-quality data and participant safety. You will leverage guidelines and disease-area knowledge to guide data cleaning, study deliverables, and collaboration with internal and external teams. This role offers meaningful impact in shaping data review processes and study execution within scope, budget, and timelines.

Responsibilities

• Lead Clinical Science services per study scope from start-up through database lock
• Perform holistic participant-level and aggregate data reviews using proprietary and non-proprietary tools
• Serve as SME for eCRF design, data capture, edit checks, and ongoing data review to ensure protocol-compliant data
• Support Risk Based Quality Management (RBQM) and address risks with cross-functional teams
• Collaborate with Medical Monitoring and oversight of data review findings
• Provide protocol review from a scientific operational perspective
• Demonstrate oncology knowledge and application of criteria (CTCAE, RECIST, Lugano, etc.)
• Oversee invoicing/out of scope management and collaborate on resource planning
• Maintain Clinical Science plans, guidelines, and trackers; ensure accurate eTMF documentation
• Participate in study meetings and contribute to data review strategy and continuous improvements
• Support business development activities (e.g., bid defenses)
• May review Tables, Figures & Listings (TLFs) and CSRs as applicable

Key requirements

• Bachelor’s degree or equivalent in science or health-related discipline
• Minimum 8 years of clinical research experience
• Minimum 3 years Oncology experience (within past 1.5 years)
• Minimum 1 year of leadership experience
• High proficiency with Microsoft Office products
• Strong organization, communication, and interpersonal skills
• Professional English (written and oral)
• Ability to travel domestically and internationally up to ~25%
• _unknown_

• customer service orientation
• attention to detail
• collaboration
• Experience with Electronic Data Capture (EDC) systems
• Database build experience
• Data review tools and platforms

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