Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Head of Clinical Data Engineering & Programming

This executive leadership role provides enterprise-level accountability across Statistical Programming and Clinical Data Programming, integrating deep technical expertise with strategic, operational, and talent leadership. The position is responsible for shaping a scalable, future-ready programming organization that consistently delivers high-quality study outcomes, enables regulatory confidence, advances standardization and automation, and strengthens the organization’s strategic differentiation.

1. Position Summary

• Strategic mandate and enterprise value of the role
• Leadership scope spanning Statistical Programming and Clinical Data Programming
• Integration of strategic oversight with hands-on technical credibility
• Reporting structure and organizational significance

2. Key Responsibilities

• Set and lead the end-to-end programming strategy across clinical studies, programs, and portfolios
• Provide executive oversight for the development and delivery of programming outputs, datasets, listings, tables, figures, and study-level deliverables
• Establish a high-performance environment that ensures consistency, quality, compliance, and inspection readiness across programming activities
• Serve as the senior technical authority for complex programming challenges, standards, and delivery risk resolution
• Shape strong cross-functional partnership with Biostatistics, Clinical Data Management, Medical Writing, Regulatory, and study leadership
• Champion standardization, automation, and modern technology adoption to improve delivery effectiveness and scalability
• Provide governance and strategic oversight of external partners, CRO relationships, and flexible delivery models

3. Leadership and Team Management

• Build and lead a high-performing, future-ready programming organization with strong succession and capability depth
• Define organizational design, capability strategy, and resource planning to support business growth and delivery resilience
• Set clear strategic priorities, performance expectations, and governance mechanisms to drive operational excellence
• Develop leadership bench strength through active coaching, mentoring, and sponsorship of technical and business talent
• Foster a culture of accountability, collaboration, and innovation across global, matrixed, and cross-functional teams

4. Technical and Operational Excellence

• Set the strategic direction for programming standards, validation frameworks, and reusable delivery assets
• Ensure sustained regulatory submission readiness and alignment with applicable industry and customer standards
• Strengthen data integrity, traceability, audit readiness, and documentation rigor across the programming lifecycle
• Maintain technical relevance across SAS, R, Python, and emerging clinical data technologies to guide strategic decisions and complex problem-solving
• Advance simplification, productivity, and automation strategies that improve quality, speed, and scalability

5. Cross-Functional Collaboration

• Serve as a senior partner to clinical operations, biostatics, data management, regulatory, quality, and technology stakeholders
• Represent programming leadership in governance forums, strategic planning, and executive decision-making discussions
• Align programming investment and execution priorities with portfolio needs, delivery commitments, and business objectives
• Engage credibly with customers, sponsors, and executive stakeholders to strengthen trust, transparency, and strategic partnership

6. Qualifications and Experience

• Advanced degree or equivalent experience in statistics, biostatistics, computer science, mathematics, life sciences, or a related discipline
• Extensive leadership experience across statistical programming and clinical data programming within pharma, biotech, or CRO environments
• Demonstrated success leading global, matrixed, and high-performing technical organizations
• Strong command of clinical trial delivery, regulatory expectations, and applicable industry standards
• Proven ability to integrate strategic leadership with deep technical credibility and operational judgment

7. Preferred Leadership Attributes

• Strategic enterprise thinker with strong execution discipline and operational rigor
• Hands-on executive leader with the judgment to engage deeply where complexity or risk requires
• Influential communicator with executive presence and the ability to align senior stakeholders
• Transformational leader who can modernize operating models and accelerate innovation
• Strong commitment to quality, compliance, talent stewardship, and customer impact

8. Innovation and Business Acumen

• Identify and advance strategic opportunities to modernize programming through automation, AI, and digital enablement
• Translate enterprise priorities into scalable programming strategies that enhance value, speed, quality, and differentiation
• Balance technical excellence with commercial discipline, resource optimization, and delivery efficiency
• Strengthen organizational differentiation by building capabilities valued by customers, sponsors, and internal stakeholders
• Use data, performance metrics, and market insight to guide investment decisions, innovation priorities, and operating model evolution

9. Success Measures

• Consistent delivery of high-quality programming outcomes aligned to study, portfolio, and customer commitments
• Sustained regulatory confidence, inspection readiness, and submission excellence
• Measurable progress in standardization, productivity, automation, and operational scalability
• A strong, engaged, and scalable leadership and technical talent pipeline
• Trusted cross-functional partnership and visible business impact across the organization