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Jobs · Writing · Massachusetts

Head of Statistical Programming

Alexion Pharmaceuticals, Inc. · Boston, MA · 2 wk ago
Writing$257k–$386k/yrFull-time

Introduction

To set the global programming strategy that accelerates life-changing therapies for people with rare and devastating diseases.

Accountabilities

  • Programming Strategy and Direction: Set the strategic direction for statistical programming within Quantitative Sciences, aligning therapy areas and enterprise priorities to deliver consistent, submission-ready outputs.

  • AI and Technical Innovation: Lead the evolution of advanced analytics, automation, and AI strategies that improve data analysis and operational delivery, from standards-based programming to intelligent tooling.

  • Quality and Compliance Oversight: Define and own the programming strategy for quality oversight across the drug portfolio, ensuring compliance with CDISC and other global standards while embedding automation for reliability and reproducibility.

  • People and Leadership: Lead a group of programming leaders; craft and execute the people development strategy to build deep technical excellence and leadership capabilities across the function.

  • External Partnerships and Outsourcing: Shape and govern outsourcing strategies with Contract Research Organisations and other partners to ensure on-time, high-quality deliverables; contribute to global partner governance.

  • Statistical Analysis Environments and Tooling: Oversee the development, implementation, administration, and budget management of statistical analysis environments used for development, reporting, and global regulatory submissions.

  • Budget and Strategic Planning: Plan and manage a complex departmental budget; forecast quarterly, annual, and multi-year needs; provide inputs to the corporation’s strategic planning process.

  • Portfolio and Capacity Management: Lead portfolio-level programming capacity planning across therapy areas/R&D, ensuring resources are proactively aligned to enterprise priorities.

  • Continuous Improvement and Change: Drive continuous improvement and large-scale change initiatives within the function and across R&D, increasing efficiency and elevating quality.

  • Regulatory and Payer Submissions: Provide strategic, scientific, and programming guidance for submissions to global regulatory and payer authorities, ensuring clarity, traceability, and inspection readiness.

Essential Skills/Experience

  • Proven track record setting the strategic direction of Programming within Quantitative Sciences.

  • At least 10 years experience leading the development of Programming strategy within a business unit while contributing to enterprise-wide Programming strategy, including leadership of broader Quantitative Sciences strategy.

  • Major contributions to or leadership of strategic initiatives, including developing and executing AI and other technical strategies related to data analysis and operational delivery.

  • Responsibility for people development strategy within a programming function and leadership of a group of leaders.

  • Accountability for the programming strategy for quality oversight of a drug portfolio.

  • Expertise developing and executing outsourcing strategies to maintain the highest quality of programming deliverables; contributions to global governance of external partners (e.g., CROs).

  • Experience with the development, implementation, administration, and budget management of statistical analysis environments utilized in the development, reporting, and submission of global regulatory dossiers.

  • Demonstrated ability to plan and manage complex departmental budgets, with accountability for quarterly, annual, and multi-year forecasting and input to corporate strategic planning.

  • Accountability for compliance to standards and automation usage (including AI, CDISC, etc.) across therapy areas/R&D units.

  • Delivery of continuous improvement and large-scale change projects within the function or across R&D.

  • Leadership of portfolio-level programming capacity management for a therapy area/R&D unit.

  • Provision of strategic, scientific, and programming advice to teams regarding submission of programming deliverables to global regulatory and payer authorities.

  • Leadership of leaders within a Programming organization.

Desirable Skills/Experience

  • Advanced degree in statistics, biostatistics, computer science, mathematics, engineering, or a related discipline.

  • Deep expertise with CDISC standards and modern statistical programming languages and tools (e.g., SAS, R, Python) and their application in validated environments.

  • Hands-on leadership establishing and operating scalable statistical computing environments, with a strong track record in global dossier submissions.

  • Experience building AI governance and automation frameworks that improve quality, speed, and reproducibility in clinical programming.

  • Demonstrated success governing CROs/strategic suppliers at scale, including quality oversight, KPIs, risk management, and inspection readiness.

  • Change leadership across large R&D organizations, including operating model evolution and capability-building.

  • Background in rare disease, orphan indications, or other complex therapeutic areas; experience with payer/HTA submissions is a plus.

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