Kumquat Biosciences Inc. · 2 months ago
Senior Director/ Head of Statistical Programming
San Diego, CA
Full-time
Onsite
Director/Executive
$250K/yr - $300K/yr
10+ years expKumquat Biosciences Inc. is 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, overseeing programming deliverables for clinical trials and regulatory submissions while managing CROs and building internal capabilities to enable data-driven decision-making.
Alternative MedicineBiotechnologyOncologyTherapeutics
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
Qualification
Required
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
Benefits
Competitive compensation
Equity participation
Comprehensive benefits
Company
Kumquat Biosciences Inc.
Kumquat Biosciences’ vision is to develop innovative therapies to bring about sustainable and life-changing benefits to cancer patients.
11-50 employees
H1B Sponsorship
Kumquat Biosciences Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (1)
2022 (2)
2021 (2)
Funding
Current Stage
Early StageTotal Funding
$175.92MKey Investors
Loxo Oncology
2021-07-29Corporate Round· $70M
2021-02-16Undisclosed· $50M
2019-07-02Private Equity· $55.92M
Leadership Team
Pingda Ren
Co-Founder, President & COO
Carin Sandvik
VP of Finance
Recent News
Labiotech.eu
2025-09-12
2025-08-17
Company data provided by crunchbase