Clinical Data Strategist & Study Lead

Cook Group; West Lafayette (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Cook Group is seeking a Clinical Scientist to provide scientific leadership for assigned clinical studies and imaging data analysis. You will independently design studies, develop data strategies, and collaborate across Regulatory Affairs, Engineering, and Business Units to advance the clinical evidence program.

The role involves coordinating DSMB reporting, managing imaging components, and contributing to publications and presentations.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 3+ years clinical research with involvement in study design and data analysis.
• Working knowledge of GCP, ISO 14155, and FDA/international regulatory requirements.
• Experience with regulatory submissions and clinical evidence documentation preferred.
• Proven ability to independently develop clinical data strategies and design clinical studies.
• Strong analytical, written and verbal communication skills; travel up to 15%.

Responsibilities

• Develop clinical data strategies and independently design assigned clinical studies with cross-functional teams.
• Lead analysis, interpretation, and reporting of clinical and imaging data to stakeholders.
• Prepare regulatory submissions and data responses; coordinate with Regulatory Affairs on plans.
• Coordinate DSMB data summaries, patient summaries, and meeting attendance.
• Develop and execute publication and presentation plans for assigned studies.

Skills

GCP knowledge

Data analysis

Communication skills

AI concepts fluency

Regulatory understanding

Travel flexibility

Independent decision making

Education

Bachelor’s degree in Life Sciences/Engineering

Master’s or PhD preferred

Tools

Imaging core lab coordination

Job description

Cook Group is seeking a Clinical Scientist to provide scientific leadership for assigned clinical studies and imaging data analysis. You will independently design studies, develop data strategies, and collaborate across Regulatory Affairs, Engineering, and Business Units to advance the clinical evidence program.

The role involves coordinating DSMB reporting, managing imaging components, and contributing to publications and presentations.