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Senior Director, Head of Statistical Programming

Princeton, New Jersey, United States

About Us 

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.

It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.
 
Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.
 
We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.
 
At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.
 
These values are the foundation of our work, empowering us to make a real difference, every day.
 
 

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 

  • 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. 

About You 

Basic Qualifications 

  • 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. 

Preferred Qualifications 

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

 

Exact Compensation may vary based on skills, experience and location.

Pay range

$248,000 - $323,000 USD

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