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Senior Director/ Head of Statistical Programming
Senior Director/ Head of Statistical ProgrammingKumquat Biosciences Inc • San Diego, CA, United States
Senior Director / Head of Statistical Programming

Senior Director / Head of Statistical Programming

Kumquat Biosciences Inc • San Diego, CA, United States
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

We are seeking a highly motivated Senior Director / Head of Statistical Programming to establish and lead the programming function in a dynamic biotech environment. This role combines strategic leadership with hands-on technical contribution, supporting early- to late-phase oncology and other therapeutic programs. The successful candidate will oversee programming deliverables for clinical trials and regulatory submissions, manage CROs, and build internal capabilities to enable data-driven decision-making and accelerate drug development.

Key Responsibilities

Leadership & Strategy

  • Define and lead the statistical programming vision, strategy, and operating model in a growing biotech setting.
  • Serve as the functional lead for programming across all studies and development programs.
  • Provide expert input into protocol design, SAP development, and regulatory strategy.

Execution & Delivery

  • Oversee and contribute to the creation of high-quality analysis datasets (ADaM), TFLs, and SDTM conversions to support clinical study reporting and regulatory submissions.
  • Act as programming lead for NDA / BLA / MAA deliverables, ensuring compliance with CDISC, ICH, and regulatory standards.
  • Implement efficient processes, templates, and standards to maximize quality and productivity in a resource-constrained environment.
  • Proactively troubleshoot and provide technical solutions for complex programming challenges.

    • Collaboration & Oversight

  • Partner closely with Biostatistics, Data Management, Clinical, and Regulatory teams to ensure alignment and timely delivery.
  • Manage and oversee CROs / vendors, ensuring deliverables meet quality, cost, and timeline expectations.
  • Represent statistical programming in cross-functional governance meetings, study teams, and regulatory interactions.

    • Team Building & Mentorship

  • Recruit, mentor, and develop a small but high-impact programming team.
  • Foster a culture of collaboration, accountability, and continuous learning.
  • Provide training, technical guidance, and career development support to staff.

    • Why Join Us

  • Opportunity to shape and build the statistical programming function in a growing biotech.
  • High-impact role with direct influence on advancing innovative therapies to patients.
  • Collaborative, entrepreneurial culture with strong scientific focus.
  • Competitive compensation, equity participation, and comprehensive benefits.

    • Requirements

  • MS / PhD in Statistics, Biostatistics, Computer Science, Mathematics, or related field.
  • 10+ years of statistical programming experience in the pharmaceutical / biotech industry, with proven experience leading programming support for regulatory submissions.
  • Strong hands-on programming expertise in SAS; proficiency in R and / or Python highly desirable.
  • Excellent knowledge of CDISC (SDTM, ADaM), ICH, and regulatory guidance.
  • Demonstrated success managing CROs and delivering results in a fast-paced, resource-lean biotech environment.
  • Strong leadership, communication, and problem-solving skills, with ability to influence and collaborate across functions.
  • Passion for building teams and infrastructure from the ground up.

    • Salary Details

    $250k - $300k yearly

    Salary Description

    $250k - $300k

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