“Head of Clinical Data Engineering & Programming
Summary
Lead the clinical data engineering and statistical programming organization, overseeing datasets, tables, and figures across clinical studies while driving standardization, automation, and AI initiatives using SAS, R, and Python in a life sciences setting.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Head of Clinical Data Engineering & Programming based in United States.
This executive leadership role will define and lead the strategic direction of clinical data engineering and statistical programming across studies, programs, and portfolios.
You will build a scalable, future-ready organization that combines technical excellence with operational discipline and strong talent leadership.
The role has broad enterprise impact, supporting high-quality clinical outcomes, regulatory confidence, submission readiness, and customer trust.
You will partner closely with Biostatistics, Clinical Data Management, Regulatory, Clinical Operations, Technology, and other senior stakeholders.
A key focus will be advancing standardization, automation, AI, and modern programming technologies to improve quality, speed, and scalability.
You will also oversee external partners and delivery models while ensuring strong governance, resource planning, and execution.
This opportunity is ideal for an experienced life sciences technology leader who can combine deep technical credibility with strategic vision and executive presence
Accountabilities:
- Define and lead the end-to-end programming strategy across clinical studies, development programs, and portfolios, aligning technical priorities with broader business and delivery objectives.
- Provide executive oversight of programming deliverables, including datasets, listings, tables, figures, statistical outputs, and other study-level materials.
- Establish governance, quality standards, and operating practices that promote consistency, compliance, inspection readiness, and reliable delivery across programming activities.
- Serve as the senior technical authority for complex programming challenges, standards, delivery risks, and critical decision-making.
- Build and lead a high-performing global programming organization, establishing organizational design, resource strategies, succession plans, and capability development programs.
- Set clear priorities, performance expectations, and governance mechanisms while fostering a culture of accountability, collaboration, innovation, and continuous improvement.
- Coach, mentor, and sponsor technical and business leaders to strengthen the organization's leadership pipeline and long-term capabilities.
- Establish strategic direction for programming standards, validation frameworks, reusable assets, and modern delivery methodologies.
- Strengthen data integrity, traceability, documentation, audit readiness, and regulatory submission preparedness throughout the programming lifecycle.
- Guide strategic decisions involving SAS, R, Python, and emerging clinical data technologies, maintaining sufficient technical depth to address complex challenges.
- Champion automation, AI, digital enablement, and process simplification initiatives that improve productivity, quality, scalability, and delivery speed.
- Partner with Biostatistics, Clinical Data Management, Clinical Operations, Medical Writing, Regulatory, Quality, Technology, and study leadership to align programming priorities with portfolio needs.
- Represent programming leadership in governance forums, strategic planning activities, and executive-level decision-making.
- Manage strategic relationships with customers, sponsors, CROs, external partners, and other stakeholders, ensuring transparency, accountability, and high-quality delivery.
- Evaluate data, performance metrics, market developments, and emerging technologies to guide investment decisions, innovation priorities, and operating-model evolution.
- Ensure programming capabilities support customer expectations and create measurable differentiation through technical excellence, efficiency, and strategic value.
- Track success through consistent delivery, regulatory confidence, operational scalability, automation progress, talent development, and strong cross-functional partnerships.
- Advanced degree or equivalent professional experience in statistics, biostatistics, computer science, mathematics, life sciences, or a related discipline.
- Extensive leadership experience spanning statistical programming and clinical data programming within pharmaceutical, biotechnology, CRO, or a comparable life sciences environment.
- Demonstrated success leading global, matrixed, high-performing technical organizations with responsibility for strategy, delivery, talent, and operational performance.
- Strong knowledge of clinical trial delivery, regulatory expectations, submission processes, programming standards, and relevant industry requirements.
- Deep technical credibility across clinical programming environments, with working knowledge of technologies such as SAS, R, Python, and emerging clinical data platforms.
- Proven ability to combine enterprise-level strategic thinking with hands-on technical judgment when addressing complex or high-risk challenges.
- Experience developing scalable operating models, programming standards, validation frameworks, reusable assets, and automation strategies.
- Demonstrated ability to lead transformation initiatives involving automation, AI, digital technologies, standardization, and process optimization.
- Strong executive presence and communication skills, with the ability to influence senior stakeholders, customers, sponsors, and cross-functional leadership teams.
- Excellent organizational and operational judgment, including experience with resource planning, performance management, governance, and delivery risk management.
- Strong commercial and business acumen, with the ability to balance technical excellence with customer value, resource optimization, delivery efficiency, and organizational growth.
- Strategic, transformational leadership style combined with strong execution discipline, accountability, and commitment to quality and compliance.
- Ability to build trusted relationships across global, cross-functional, and matrixed environments while fostering collaboration and innovation.
- Opportunity to lead an enterprise-level clinical data engineering and programming organization with significant strategic and operational impact.
- Exposure to complex clinical development programs, regulatory requirements, advanced analytics, automation, AI, and emerging technologies.
- Ability to shape the future operating model, technical capabilities, talent strategy, and innovation agenda for a global programming organization.
- Collaborative environment with senior partnerships across Clinical Operations, Biostatistics, Data Management, Regulatory, Quality, Technology, and other functions.
- Opportunities to influence strategic decisions and work directly with senior executives, customers, sponsors, and external partners.
- Career growth through enterprise leadership, organizational transformation, and ownership of high-visibility strategic initiatives.
- Standard Monday–Friday work schedule in an office environment.
- Comprehensive employment benefits and professional development opportunities, subject to the applicable employment package and eligibility requirements.
Requirements:
Benefits:
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