Senior Director/ Head of Statistical Programming

Kumquat Biosciences Inc • San Diego, CA

68d • $250,000 - $300,000

About The Position

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.

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.

Responsibilities

• 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.
• 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.
• 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.
• 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.

Benefits

• Competitive compensation
• Equity participation
• Comprehensive benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree