Senior Bioanalytics & Data Integration Project Manager

Position Summary:
We are seeking an experienced Senior Data Science Project Manager to lead strategic data and digital transformation initiatives supporting regulated bioanalytical workflows. This role will serve as the project lead for complex data science and integration efforts, partnering across scientific, informatics, IT, and operational teams to deliver scalable, compliant, and business-impacting data solutions.
The successful candidate will be responsible for developing project frameworks, data integration strategies, and analytical solutions that support critical laboratory operations while ensuring compliance with FDA 21 CFR Part 11, GxP, GDPR, and corporate data governance requirements.
Key Responsibilities:
Project Leadership & Strategy
Lead complex data science initiatives from concept through implementation.
Develop and manage project frameworks, roadmaps, timelines, and governance structures.
Drive cross-functional collaboration among bioanalytical scientists, informatics teams, data engineers, and business stakeholders.
Translate business requirements into technical data solutions that improve operational efficiency and scientific decision-making.
Identify risks, dependencies, and mitigation strategies while managing project execution.
Data Integration & Analytics
Lead planning and execution of instrument-to-LIMS integration initiatives.
Develop strategies for integrating laboratory, operational, and business data sources.
Support the design of scalable data models and integration architectures.
Oversee development and validation of SQL queries and Python-based workflows for data extraction, transformation, and reporting.
Ensure data quality, consistency, and traceability across analytical platforms.
Business Intelligence & Operational Excellence
Support the evolution and maintenance of departmental Common Operating Picture capabilities.
Collaborate with leadership to define KPIs, performance metrics, and reporting frameworks.
Build dashboards and analytics that provide actionable operational insights.
Enable data-driven decision making through visualization and performance measurement tools.
Compliance & Governance
Ensure solutions comply with FDA 21 CFR Part 11 requirements.
Maintain adherence to GxP, GDPR, and internal quality standards.
Support validation activities, audit readiness, and documentation requirements.
Implement data governance and lifecycle management best practices.
Partner with Quality and Compliance teams to ensure regulatory expectations are met.
Basic Minimum Qualifications:
Bachelor's degree in Data Science, Computer Science, Bioinformatics, Statistics, Engineering, Life Sciences, or related discipline.
7+ years of experience leading data science, analytics, informatics, or digital transformation projects.
Demonstrated experience managing cross-functional technical initiatives in regulated environments.
Strong project management and stakeholder engagement skills.
Experience with:
SQL
Python
Data integration and ETL processes
Dashboarding and data visualization platforms
LIMS, laboratory systems, or scientific data environments
Knowledge of FDA 21 CFR Part 11, GxP, and data governance principles.
Must be eligible to work in the United States indefinitely without restriction or sponsorship
Preferred Qualifications:
Advanced degree (MS, MBA, PhD) in a relevant discipline.
Pharmaceutical, biotechnology, CRO, or life sciences industry experience.
Experience supporting bioanalytical, clinical, translational, or laboratory operations.
Familiarity with cloud-based analytics platforms and modern data architectures.
Experience implementing enterprise data solutions at scale.

Employment type
Full-time

Work arrangement
No