Senior Director, Head of Statistical Programming

Kardigan; Princeton (NJ); On-site; USD 248,000 - 323,000; Full time

Job summary

Kardigan is seeking a Senior Director, Head of Statistical Programming to guide strategy, organization, and quality of programming across its cardiovascular portfolio. The role will lead internal teams and oversee CRO partnerships, establishing scalable standards and a compliant environment for regulatory submissions.

Ideal candidates bring 10+ years in statistical programming within pharma/biotech, strong CDISC expertise, and proven vendor management.

Qualifications

• Master's degree or PhD in a quantitative field.
• 10+ years of statistical programming experience in pharma/biotech.
• Proven experience leading a team of statistical programmers.
• Demonstrated experience leading regulatory submissions (NDA/BLA) and health authority interactions.
• CDISC SDTM/ADaM knowledge and familiarity with define.xml and submission packages.
• Experience managing vendors, CROs, budgets, and resource planning.

Responsibilities

• Lead Statistical Programming organization and oversee CROs/contractors.
• Ensure timely delivery of analysis datasets, tables, figures, listings, and documentation.
• Oversee SDTM, ADaM, define.xml, and submission components per regulatory standards.
• Maintain programming standards, validation frameworks, and QA processes.
• Collaborate with Biostatistics, Data Management, Regulatory, Quality, and IT.

Skills

Leadership

Regulatory submissions

Cross-functional collaboration

Vendor management

Strategic planning

Education

Master's degree or PhD in Statistics/Biostatistics/Math/CS

Tools

SAS

R

Git

Job description

Senior Director, Head of Statistical Programming

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 producesanalysisdatasets, 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 whilemaintainingthehighest standards of quality, ethics, and compliance, supporting our mission to bring transformative treatments to people living with cardiovascular disease.

JobOverview

Kardiganisseekingan experienced and forward‑looking leader to serve as Head of Statistical Programming. This individual will be accountable for the strategy, organization, quality, andtimelydelivery of statistical programming acrossKardigan’sclinical portfolio. The role will lead and develop the internal programming team, oversee CRO and contractor partnerships,establishscalable programming standards and quality processes, and provide functional leadership for regulatory submissions and health‑authority interactions.The Head of Statistical Programming will also shapeKardigan’sprogramming technology andoperating‑model roadmap, including the effective use of SAS, R, automation, reusable tools, and a validated statistical computing environment. The successful candidate will combine strong technicalexpertisewith 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, andmaintainSOPs andprogrammingstandards 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, ensuringtimelydelivery 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 componentsin accordance withregulatory 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 andmaintainprogramming standards, SOPs, validation frameworks, and quality processes that ensure consistency, regulatory compliance, data integrity, traceability, andinspectionreadiness.
• Ensureappropriate qualitycontrol, 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 businessobjectives.

Technology and Cross‑Functional Leadership

• Establish andmaintaina validated, regulatory‑compliantstatistical 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, ora relatedquantitativefield.
• 10+ years of statistical programming experience within the pharmaceutical, biotechnology, or clinical research industry.
• Proven experience leading and managing a team ofstatisticalprogrammers.
• Demonstrated experience leading major regulatory submissions, including NDA/BLA filings and health authority interactions.
• Comprehensive knowledge of CDISC standards (SDTM andADaM), regulatory submission requirements, define.xml, reviewer guides, and electronic submission packages.
• Strong understanding of the clinical development lifecycle, statistical analysis, study reporting,submissionreadiness, 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 whileremainingtechnically credible and hands‑on when needed.

Preferred Qualifications

• Experience in cardiovascular clinical development is desirable.
• Expertisein 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

Voluntary Self‑Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forged in Kardigan’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

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An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.