Senior Director, Head of Statistical Programming

Kardigan•Princeton, NJ

About The Position

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.

Requirements

Master's degree or PhD in Statistics, Biostatistics, Mathematics, Computer Science, or a related quantitative field.
10+ years of statistical programming experience within the pharmaceutical, biotechnology, or clinical research industry.
Proven experience leading and managing a team of statistical programmers.
Demonstrated experience leading major regulatory submissions, including NDA/BLA filings and health authority interactions.
Deep expertise in SAS
Comprehensive knowledge of CDISC standards (SDTM and ADaM), regulatory submission requirements, define.xml, reviewer guides, and electronic submission packages.
Strong understanding of the clinical development lifecycle, statistical analysis, study reporting, submission readiness, and regulatory compliance.
Experience managing vendors, CROs, outsourced deliverables, budgets, and resource planning.
Experience supporting regulatory inspections, audits, validated computing environments, and data integrity requirements.
Ability to provide strategic leadership while remaining technically credible and hands-on when needed.

Nice To Haves

Experience in cardiovascular clinical development is desirable.
Expertise in R, modern open-source programming practices, and version-control platforms such as Git.

Responsibilities

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.
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.
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.
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.
Establish and maintain a validated, regulatory-compliant statistical computing environment that supports efficient analysis and regulatory submissions.
Drive the adoption of automation, reproducible programming, code review, standardization, and reusable programming solutions.
Provide technical leadership for complex programming initiatives and collaborate effectively with Biostatistics, Data Management, Clinical Operations, Regulatory Affairs, and other key stakeholders.
Define and communicate operational metrics, portfolio status, risks, and resource requirements to senior leadership.