Research Data Scientist

Job Summary and Purpose: The Research Data Scientist is responsible for organizing the systems for collection, handling, reviewing, and analysis of data to support timely submission of reports to regulatory agencies (i.e., USDA, CFIA, and FDA). The Research Data Scientist ensures integrity, accuracy, and regulatory compliance of research data, in alignment with R&D processes, standard operating procedures (SOPs), and applicable standards.

Responsibilities and Key Duties:

Trial and Experimental Data Oversight

• Lead and optimize entry processes and data review to ensure accuracy, completeness, enhance efficiency, and minimize bottlenecks in submissions to government agencies.
• Review raw data and electronic trial documents during studies.
• Collaborates with study teams, biostatisticians, and regulatory teams to ensure the integrity and validity of study results.
• Develop and implement new processes as needed to support regulatory compliance, efficient data record management, data analysis, and duties as assigned.
• Provide training and guidance to study teams and CRO staff on SOP and documentation standards, data auditing, peer review, and data analysis.

Master Seed/Sequence/Cell Coordination

• Manage systems for tracking and controlling master seeds, cells, and sequences in compliance with USDA requirements and internal SOPs.
• Ensure supporting documentation (e.g., process records, certificates of analysis, media records, inventories, extraneous agent testing) is complete and available.
• Oversee documentation and shipping of master seeds and cells to USDA.

Archiving

• Ensure study binders and notebooks are complete, properly organized, and accurately logged into the inventory system with correct storage locations.

• Verify data integrity, compliance and traceability of electronic laboratory notebooks (ELN) for archiving.

• Maintain archiving systems (CAT) in compliance with regulatory requirements.

• Serves as an R&D representative during USDA audits, responsible for retrieving and providing requested records and SOPs.

• All other duties as assigned

Do you have experience in Updating inventory records?, Do you have a Master's degree?, * Experience working with databases, with preferred knowledge of database structures, electronic data capture (EDC) systems and relational data models

• Understanding of statistical analysis

• Skilled in Microsoft Office Suite, with high proficiency in Microsoft Excel, including advanced functions, pivot tables, and data visualization tools.

• Familiarity with artificial intelligence applications in data analysis, automation, or decision support

• Understanding of government biologics regulations and compliance standards, especially in data integrity and reporting

Core Competencies:

• Shape solutions out of complexity

• Client focus

• Collaborate with empathy

• Engage and develop

• Drive ambition and accountability, Education and experience: Bachelor's degree in an analytical or life science-related field with 4+ years of related work experience OR Master's degree in an analytical or life science-related field with 3+ years of related work experience OR Ph.D. in an analytical or life science-related field with 2+ years of related work experience required.

Physical Requirements:

• Visual inspection

• Bending

• Lifting to 25 pounds, Education and experience: Bachelor's degree in an analytical or life science-related field with 4+ years of related work experience OR Master's degree in an analytical or life science-related field with 3+ years of related work experience OR Ph.D. in an analytical or life science-related field with 2+ years of related work experience required

As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet. We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife. Indeed, Our "Together, Beyond Animal Health" vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.