Clinical Data Scientist: Regulatory Trials & Analytics

DiaSorin; Austin (TX); On-site; USD 110,000 - 150,000; Full time

Job summary

DiaSorin in Austin, TX seeks a Clinical Data Scientist to develop, source and maintain clinical data tools, databases and software for in vitro diagnostic products. Role ensures data accuracy and regulatory compliance (GCP/GLP, FDA) across studies, with cross-functional collaboration across Clinical Development, Legal, and Marketing.

The ideal candidate will hold a molecular biology/biochemistry advanced degree with strong data analysis, programming for data mining, and experience in regulated

Qualifications

• Bachelor's/Master's/PhD in molecular biology/biochemistry with regulated clinical research experience
• Strong communication, writing and presentation skills
• Experience in data analysis and regulatory literature review
• Experience or knowledge of FDA-regulated environments
• Documentation and record management for labs and clinical studies (GLP/GCP)

Responsibilities

• Ensure accuracy and integrity of clinical study databases
• Lead database training and user access
• Enter and validate studies in the database
• Prepare reports, CRFs, and database troubleshooting
• Develop/validate programming for data tracking and reporting
• Provide statistical input and analysis plans for study protocols
• Manage data management project timelines
• Monitor compliance with clinical study protocols and regulatory requirements
• Support cross-functional teams to complete tasks on time
• Carry out internal auditing of clinical databases

Education

Bachelor's Degree in Molecular Biology / Biochemistry or related discipline

Master's Degree in Molecular Biology / Biochemistry or related discipline

Ph.D. in Molecular Biology / Biochemistry or related discipline

Superior communication, presentation and writing skills

Organizational/time-management skills

Programming for clinical data mining

Experience in molecular and clinical data analysis

Experience with GLP and GCP documentation

FDA-regulated environment knowledge

Job description

DiaSorin in Austin, TX seeks a Clinical Data Scientist to develop, source and maintain clinical data tools, databases and software for in vitro diagnostic products. Role ensures data accuracy and regulatory compliance (GCP/GLP, FDA) across studies, with cross-functional collaboration across Clinical Development, Legal, and Marketing.

The ideal candidate will hold a molecular biology/biochemistry advanced degree with strong data analysis, programming for data mining, and experience in regulated