Kumquat Biosciences Inc.
Senior Director/ Head of Statistical Programming
Kumquat Biosciences Inc., San Diego, California, United States, 92189
Senior Director/ Head of Statistical Programming
2 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Base pay range
$250,000.00/yr - $300,000.00/yr 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
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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2 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Base pay range
$250,000.00/yr - $300,000.00/yr 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
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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