Sr. Bioinformatics Scientist – CDSDM

Predicine, Inc; Hayward (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Predicine, Inc. in Hayward, CA, seeks a Senior Bioinformatics Scientist – CDSDM to support clinical studies and trials through rigorous data science and data management.

The role integrates clinical, assay, biomarker, genomic, sample, and operational datasets into accurate, audit-ready data assets, guiding study lifecycle data quality and reporting. The incumbent will lead cross-functional data workflows, collaborate with clinical, data management, biostatistics, regulatory, QA, and lab teams,

Qualifications

• Master's degree with 3+ years of relevant experience or Doctorate (PhD).
• Strong quantitative skills in bioinformatics, biostatistics, data science, computational biology, or related field.
• Experience in clinical study/trial data management, reporting, data transfer, or biomarker analysis is preferred.

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.

Skills

R

Python

SQL

SAS

ETL

Workflow automation

Data cleaning

Education

Master's degree with 3+ years of relevant experience

Doctorate (PhD)

Tools

DTS/DTA

Clinical data exchange

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Sr. Bioinformatics Scientist – CDSDM

Full Time Professional Hayward, CA, US

5 days ago Requisition ID: 1100

About Predicine

Predicine Inc. is a precision oncology company advancing the fight against cancer through cutting-edge genomic technologies and liquid biopsy solutions. We partner with pharmaceutical companies, clinicians, and researchers worldwide to bring next-generation diagnostics from bench to bedside — faster, smarter, and more accessible. Join a team where your work directly impacts patient outcomes and the future of cancer care.

Position Overview:

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.

Job Summary

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.

What You'll Do

Key Responsibilities & Time Allocation

% of Time

Responsibility

30% Clinical Data Management & Analysis — Lead clinical study/trial data management and analysis, including data plans, integration, cleaning, reconciliation, QC, and analysis-ready dataset generation.

20% Reporting & Workflow Tools — Develop and maintain clinical reporting, DTS/DTA, data transfer, ETL, and workflow automation tools for test and production data.

20% Data Specifications & Documentation — Define and maintain data specifications, data dictionaries, CRF/sample data requirements, validation documentation, and audit-ready records.

20% Multi-Source Data Integration — Integrate clinical metadata, assay results, NGS/biomarker data, sample tracking, and outcome data for study reporting and interpretation.

10% Reporting & Stakeholder Deliverables — Generate reproducible tables, listings, figures, dashboards, reports, and written summaries for internal and external stakeholders.

What You Bring

Education

Minimum

Preferred

Level Master's degree with 3+ years of relevant experience Doctorate (PhD)

Field of Study Bioinformatics, Biostatistics, Data Science, Computational Biology, Biomedical Informatics, Clinical Research, or related field Same fields

Experience

Minimum

Preferred

Work Experience 2+ years in clinical study/trial data management, clinical reporting, DTS/data transfer, or biomarker analysis Oncology diagnostics, NGS/biomarker data, clinical outcomes, or regulated clinical reporting experience

Required Skills & Qualifications

• Strong R and/or Python data analysis skills; SQL, SAS, ETL, or workflow automation experience is a plus
• 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

Preferred Skills & Qualifications

• Experience with oncology diagnostics, NGS/biomarker data, clinical outcomes, or regulated clinical reporting
• Pharma, biotech, CRO, central-lab, or clinical research industry experience

Join Us

At Predicine, you won't just manage data — you'll build the traceable, audit-ready foundation that makes cancer diagnostics and clinical trials trustworthy. If you're detail-driven, thrive on cross-functional collaboration, and want your work to directly support better patient outcomes, we want to hear from you.

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