Head of Analytical Data & Statistics

Head of Analytical Data & Statistics

Location: Boston, MA, USA

Job Type: Full-time

Work Model: Hybrid

Salary: $177,000 – $278,080 per year

We are seeking an experienced Head of Analytical Data & Statistics to lead analytical data, statistics and data governance capabilities within a biotechnology or pharmaceutical R&D environment.

This senior leadership role will establish statistical and analytical standards, strengthen data quality and governance, and embed advanced analytics into experimental design, analytical development and strategic decision-making.

You will lead a multidisciplinary team while partnering closely with Analytical Development, Quality, Regulatory, Digital, Informatics, Manufacturing and other cross-functional stakeholders.

Key Responsibilities

• Lead and develop the Analytical Data & Statistics function, including hiring, coaching, capability development and performance management
• Establish and continuously improve statistical standards, analytical methodologies, data governance frameworks and reporting practices
• Develop the strategy and roadmap for how analytical data and statistics support research, development and portfolio decisions
• Oversee data architecture, collection, validation, quality control, metadata and data-integrity processes
• Embed statistical analysis and analytics into experimental and assay design and key project milestones
• Develop and govern statistical analysis plans, acceptance criteria and analytical frameworks for method development, qualification, validation and lifecycle management
• Provide statistical and analytical expertise for complex technical and scientific questions
• Present analytical insights, risks and recommendations to senior leadership to support strategic decisions and prioritisation
• Evaluate and implement modern analytics technologies, automation, advanced modelling and AI-assisted analytical approaches where appropriate
• Establish reproducible and scalable analytical workflows, including standards, templates, libraries and validated processes
• Partner with IT, laboratory informatics and data-platform teams to improve integration across LIMS, ELN, CDS and data-lake environments
• Ensure analytical data and statistical practices meet applicable GxP, data integrity and regulatory requirements
• Promote technical excellence through training, peer review, knowledge sharing and communities of practice
• Identify opportunities to improve analytical processes, reduce rework and increase the speed, quality and scalability of data-driven decision-making

Technical & Functional Requirements

• Advanced degree (PhD or Master's) in Statistics, Biostatistics, Data Science, Bioinformatics or a related discipline
• Extensive experience in statistical analysis and data management within the biotechnology or pharmaceutical industry
• Strong experience in Analytical Development (AD) within biologics and/or small-molecule environments
• Deep knowledge of applied statistical methods, including:
• Design of Experiments (DoE)
• Regression and multivariate analysis
• Variance components
• Measurement system analysis
• Stability trending
• Comparability assessments
• Strong understanding of analytical data generated through chromatography, electrophoresis, mass spectrometry, potency assays and bioassays
• Experience defining statistical analysis plans, data standards and fit-for-purpose acceptance criteria
• Proficiency with R, Python, SAS or equivalent statistical/analytics tools
• Experience with reproducible analytical workflows, version control and code review
• Strong data visualisation and dashboarding capabilities
• Familiarity with LIMS, ELN, CDS, data lakes and analytical informatics ecosystems
• Strong understanding of GxP, ALCOA+, audit trails and computerized-system validation
• Experience applying statistical and analytical methods to support method development, qualification, validation and lifecycle management
• Knowledge of AI/ML and modern analytical technologies is advantageous

Leadership & Strategic Skills

• Proven experience leading and developing high-performing analytics, statistics or data teams
• Ability to establish a clear analytical data strategy and align resources, priorities and technology roadmaps with business objectives
• Strong cross-functional leadership and stakeholder-management skills
• Ability to influence scientific and technical teams and drive adoption of data-driven ways of working
• Excellent communication skills, with the ability to translate complex statistical analysis into clear, decision-ready recommendations
• Strong scientific judgement and ability to communicate uncertainty, risk and analytical limitations
• Strategic, pragmatic and commercially aware approach to prioritisation and resource allocation
• Comfortable making high-impact decisions within a regulated, matrixed environment

Cross-Functional Collaboration

You will work closely with:

• Analytical Development: Study and assay design, analytical questions, data interpretation and milestone decisions
• Quality & Regulatory: Data integrity, inspection readiness and submission-ready statistical analysis
• Digital & IT: Data platforms, automation and analytical informatics
• Laboratory Informatics: LIMS, ELN, CDS and data integration
• Manufacturing / MSAT: Process and analytical data requirements
• Senior Leadership: Portfolio strategy, prioritisation, resource allocation and risk-based decision-making

Ideal Background

The ideal candidate combines deep statistical expertise, pharmaceutical/biotechnology experience and proven people leadership.

You should be comfortable operating at both strategic and technical levels — setting the direction for an analytical data function while also providing expert guidance on complex statistical, data-governance and analytical-development challenges.

English: Fluent

Salary: $177,000 – $278,080 per year, depending on qualifications, experience, skills and location.