Senior Director, Head of Statistical Programming

About the Team: 

Kardigan's Clinical Data Analytics team is a collaborative and technical partner in advancing our portfolio of investigational cardiovascular therapies. The team is composed of two closely aligned groups, Statistical Programming and Data Science, that turn clinical trial data into submission-ready outputs and actionable insights. Working closely with colleagues across Biostatistics, Clinical Development, and Data Management, the team produces analysis datasets, statistical outputs, dashboards, and exploratory analyses that support high-quality decisions throughout development. 

We are building a team that combines technical excellence with a forward-looking, innovation-driven mindset. Team members have the opportunity to modernize how clinical data is programmed, analyzed, and explored, applying tools like automation and AI to strengthen our work. This helps us move with speed and precision while maintaining the highest standards of quality, ethics, and compliance, supporting our mission to bring transformative treatments to people living with cardiovascular disease. 

Job Overview 

Kardigan is seeking an experienced and forward-looking leader to serve as Head of Statistical Programming. This individual will be accountable for the strategy, organization, quality, and timely delivery of statistical programming across Kardigan’s clinical portfolio. The role will lead and develop the internal programming team, oversee CRO and contractor partnerships, establish scalable programming standards and quality processes, and provide functional leadership for regulatory submissions and health-authority interactions. The Head of Statistical Programming will also shape Kardigan’s programming technology and operating-model roadmap, including the effective use of SAS, R, automation, reusable tools, and a validated statistical computing environment. The successful candidate will combine strong technical expertise with portfolio leadership, operational discipline, vendor-management experience, and the ability to collaborate effectively across Biostatistics, Clinical Data Management, Clinical Development, Regulatory, Quality, and IT. 

Functional Leadership and Organization Development 

• Build, lead, and develop a high-performing Statistical Programming organization through effective hiring, coaching, mentoring, and succession planning. 

• Develop, implement, and maintain SOPs and programming standards to ensure consistency and quality.  

• Define and evolve the Statistical Programming operating model, organizational structure, standards, and capabilities to support a growing clinical portfolio. 

• Foster a culture of accountability, collaboration, technical excellence, continuous improvement, and proactive risk management. 

Portfolio Delivery and Regulatory Submissions 

• Provide strategic and operational leadership for statistical programming activities across clinical development programs, ensuring timely delivery of high-quality analysis datasets, tables, figures, listings, and supporting documentation. 

• Lead programming strategy and execution for regulatory submissions, including NDA/BLA filings, integrated summaries, health authority interactions, and responses to regulatory inquiries. 

• Oversee the development and delivery of SDTM, ADaM, define.xml, reviewer guides, and other submission components in accordance with regulatory requirements and CDISC standards. 

• Monitor portfolio priorities, milestones, resource needs, dependencies, and risks, implementing mitigation plans as appropriate. 

• Serve as the senior Statistical Programming representative for regulatory inspections, audits, submission planning, and cross-functional governance activities. 

Quality, Compliance, Standards, and Inspection Readiness 

• Establish and maintain programming standards, SOPs, validation frameworks, and quality processes that ensure consistency, regulatory compliance, data integrity, traceability, and inspection readiness. 

• Ensure appropriate quality control, documentation, change management, and oversight of both internal and outsourced programming activities. 

• Partner with Quality and other stakeholders to address audit findings, CAPAs, and quality improvement initiatives. 

Vendor, Resource, and Budget Management 

• Develop and execute sourcing strategies using internal resources, CROs, contractors, and functional service providers. 

• Manage departmental resources, budgets, capacity planning, vendor performance, and governance processes to support business objectives. 

Technology and Cross-Functional Leadership