Bioanalytics & Data Integration Project Manager

Position Summary:
We are seeking an experienced Data Science Project Manager to lead complex data science and data integration initiatives supporting critical bioanalytical workflows within a regulated pharmaceutical research environment. The successful candidate will drive the development and implementation of data solutions that enhance operational effectiveness, support strategic decision-making, and enable compliant integration of scientific data across laboratory and business systems.
This role requires a strong combination of project leadership, data science acumen, stakeholder management, and knowledge of regulated environments, including FDA 21 CFR Part 11, GxP, and GDPR requirements. The individual will partner closely with scientific, informatics, and operational teams to develop scalable data frameworks, integration strategies, and analytical capabilities that support evolving business needs.
Key Responsibilities:
Project Leadership
Lead complex data science and analytics initiatives from concept through implementation.
Develop project frameworks, roadmaps, timelines, and governance structures to ensure successful program execution.
Coordinate cross-functional teams, including laboratory operations, informatics, data science, and business stakeholders.
Manage project risks, dependencies, communications, and deliverable tracking.
Data Science & Analytics
Design and oversee development of data solutions supporting bioanalytical and scientific workflows.
Lead the development and validation of complex SQL queries and Python-based data processing solutions.
Support data extraction, transformation, validation, and integration activities across multiple data sources.
Ensure data quality, traceability, and regulatory compliance throughout the data lifecycle.
Data Integration & Digital Transformation
Develop strategies for integrating laboratory instruments and scientific systems into enterprise platforms such as LIMS.
Support the design of data integration models and methodologies across PDMB and related organizations.
Identify opportunities to automate workflows and improve data accessibility, consistency, and usability.
Collaborate with technical teams to establish scalable data architectures and integration frameworks.
Business Intelligence & Strategic Planning
Support development and evolution of departmental performance dashboards and Common Operating Picture capabilities.
Identify key performance indicators (KPIs) and supporting metrics aligned with organizational priorities.
Provide analytical insights that inform operational, strategic, and portfolio decision-making.
Develop reporting frameworks that enable leadership visibility into performance and business outcomes.
Compliance & Quality
Ensure all solutions align with FDA 21 CFR Part 11, GxP, GDPR, and corporate data governance requirements.
Partner with Quality and Compliance teams to support validation and audit readiness activities.
Maintain appropriate documentation, testing records, and change management controls.
Basic Minimum Qualifications:
Bachelor's degree in Data Science, Computer Science, Information Systems, Bioinformatics, Engineering, Statistics, or related discipline.
5+ years of experience leading data-focused projects in a pharmaceutical, biotechnology, healthcare, or highly regulated industry.
Demonstrated experience managing cross-functional technical projects.
Strong proficiency with SQL and data querying methodologies.
Working knowledge of Python for data extraction, transformation, and analytics.
Experience implementing data solutions in regulated environments.
Strong communication and stakeholder management skills.
Authorization to work in the United States indefinitely without restriction or sponsorship.
Preferred Qualifications:
Advanced degree (M.S., MBA, or Ph.D.) in a relevant field.
Experience supporting bioanalytical, laboratory, or research operations.
Knowledge of laboratory systems, including LIMS, ELN, or scientific instrumentation platforms.
Familiarity with data visualization and reporting platforms (Power BI, Tableau, Spotfire, etc.).
Understanding of enterprise data architecture and integration technologies.
Experience operating within FDA-regulated environments.

Employment type
Full-time

Work arrangement
No