Sr. Bioinformatics Scientist – CDSDM

Predicine, Inc • Hayward, CA

2d

About The Position

The (Senior) Bioinformatics Scientist, Clinical Data Science and Data Management will support clinical studies and clinical trials through rigorous clinical data science and data management. This role integrates clinical, assay, biomarker, genomic, sample, and operational datasets into accurate, traceable, analysis-ready data assets. The position emphasizes clinical study/trial data management, clinical reporting, data transfer specifications, data quality, validation, and reproducible outputs. At the senior level, the incumbent will lead cross-functional data workflows from study setup through reporting, partnering with clinical, data management, biostatistics, regulatory, QA, project management, laboratory, and external stakeholders to ensure data integrity and audit-readiness across the study lifecycle. We are seeking highly motivated individuals to support clinical studies and clinical trials through rigorous clinical data science and data management. The incumbent will integrate clinical, assay, biomarker, genomic, sample, and operational datasets into accurate, traceable, analysis-ready data assets. The role emphasizes clinical study/trial data management, clinical reporting, data transfer specifications, data quality, validation, and reproducible outputs. For senior positions, the candidate will lead cross-functional data workflows from study setup through reporting with clinical, data management, biostatistics, regulatory, QA, project management, laboratory, and external partners. This is an exciting opportunity to join a fast-growing startup, accelerate your growth, and make a positive, immediate impact on cancer diagnosis and treatment.

Requirements

• Master's degree with 3+ years of relevant experience
• 2+ years in clinical study/trial data management, clinical reporting, DTS/data transfer, or biomarker analysis
• Strong R and/or Python data analysis skills
• Hands-on clinical study/trial data management, including cleaning, harmonization, QC, traceability, and documentation
• Familiarity with DTS/DTA, clinical data exchange, GCP/GCLP, CRFs, data dictionaries, validation, and study reporting
• Strong attention to detail, data quality, reproducibility, compliance, and audit readiness
• Excellent cross-functional communication skills

Nice To Haves

• Doctorate (PhD)
• SQL, SAS, ETL, or workflow automation experience
• Oncology diagnostics, NGS/biomarker data, clinical outcomes, or regulated clinical reporting experience
• Pharma, biotech, CRO, central-lab, or clinical research industry experience

Responsibilities

• Lead clinical study/trial data management and analysis, including data plans, integration, cleaning, reconciliation, QC, and analysis-ready dataset generation.
• Develop and maintain clinical reporting, DTS/DTA, data transfer, ETL, and workflow automation tools for test and production data.
• Define and maintain data specifications, data dictionaries, CRF/sample data requirements, validation documentation, and audit-ready records.
• Integrate clinical metadata, assay results, NGS/biomarker data, sample tracking, and outcome data for study reporting and interpretation.
• Generate reproducible tables, listings, figures, dashboards, reports, and written summaries for internal and external stakeholders.

Benefits

• Predicine is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior