Senior Director/ Head of Statistical ProgrammingKumquat Biosciences Inc • San Diego, CA, US

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Senior Director / Head of Statistical Programming

Kumquat Biosciences Inc • San Diego, CA, US

17 days ago

Job type

Full-time

Job description

Job Description

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

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Senior Director Head of Statistical Programming • San Diego, CA, US

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