About Kivu Bioscience
At Kivu Bioscience, we leverage advanced, next-generation proprietary Antibody Drug Conjugates (ADC) technologies to deliver more precise and effective cancer treatments. Utilizing Synaffix’s sitespecific conjugation platform, including the cutting-edge GlycoConnect™ technology, Kivu’s proprietary approach creates highly stable ADCs with optimized linker and payload combinations, designed to maximize therapeutic efficacy while minimizing off-tumor toxicity. By targeting aspargine-297, GlycoConnect™ produces a clean, highly homogenous product, offering a clear manufacturing advantage over other conjugation technologies. With state-ofthe-art innovations in conjugation and payload delivery, we are shaping the future of targeted oncology therapies with a commitment to improving patient outcomes and treatment tolerability. Kivu programs employ three technology pillars to deliver best-in-class ADCs by enhancing homogeneity, stability, and potency.
At Kivu Bioscience, we are driven by our mission to develop groundbreaking therapies that advance oncology treatment and improve patients’ lives. Our success stems from the strength and diversity of our team, and we are deeply committed to creating an environment where every individual can thrive. We foster a collaborative, inclusive culture built on intellectual curiosity, innovation, and a shared passion for making a difference. Our fast-paced environment encourages continuous learning, and we are fully invested in the recruitment, training, and professional growth of each team member.
Overview
The Senior Director/Executive Director, Biostatistics and Statistical Programming serves as Kivu’s biometrics leader, providing scientific and operational oversight across all biostatistics and statistical programming activities in support of Kivu’s oncology-focused pipeline. As a core member of the R&D leadership team, this individual is accountable for the strategic direction, design, execution, and regulatory delivery of biometrics across Kivu’s portfolio.
This role leads all biometrics contributions across their clinical development, IND, NDA submissions, and health authority interactions, ensuring delivery of high-quality, submission-ready datasets, analyses, and regulatory documentation compliant with global standards. The Director will be a recognized expert in oncology clinical trial design development, RECIST, safety and other applicable measurements of activity, and the statistical methodology/programming needs specific to oncology. This individual will shape critical development and regulatory decisions and serve as Kivu’s primary statistical authority in interactions with the FDA, EMA, and other global health authorities.
This role is expected to require up to 20% travel, including international travel. This role is based in San Francisco Bay Area, San Mateo County, CA with four days required in the office.
Responsibilities
Strategic and Executive Leadership
- Serve as Kivu’s senior biometrics authority, shaping the strategic direction for all biostatistics and statistical programming activities across the R&D portfolio.
- Translate corporate and product development goals into rigorous, operationally executable biometrics strategies that balance scientific defensibility, regulatory compliance, and speed of execution.
- Represent Kivu as the senior biometrics lead in interactions with the FDA, EMA, and other global health authorities — including NDA submission meetings, Type A/B/C meetings, and advisory committee preparations.
- Provide authoritative statistical leadership for oncology therapy development programs, with expertise in rare disease trial design, small patient populations, longitudinal assessments, and long-term follow-up.
- Establish and maintain biometrics standards, SOPs, and governance aligned with GCP, ICH, CDISC, and evolving regulatory expectations for advanced therapies.
- Contribute to R&D governance, portfolio prioritization, and executive-level strategic planning as a member of the senior leadership team.
Biostatistics — Early/Late-Stage and Regulatory
- Lead statistical design, analysis planning, interpretation, and reporting for all early and potentially late-stage clinical programs, including Phase 2/3 trials and pivotal studies supporting NDA submissions.
- Provide scientific leadership for protocol development, oncology endpoint selection, sample size determination, randomization, and adaptive design considerations.
- Oversee development, review, and final approval of Statistical Analysis Plans (SAPs) across all programs.
- Serve as the primary statistical resource for Data Monitoring Committees (DMCs), interim analyses, executivelevel data reviews, and governance committee presentations.
- Ensure statistical methodologies are scientifically defensible, clinically interpretable, and aligned with current FDA, EMA, and other global regulatory expectations.
Statistical Programming
- Provide strategic and hands-on operational oversight of all statistical programming activities, including CDISCcompliant SDTM and ADaM dataset development, TLF production, integrated summaries, and electronic regulatory submission deliverables.
- Establish and enforce programming standards, validation procedures, and quality control processes consistent with inspection readiness and global regulatory compliance.
- Direct oversight of CRO and statistical programming vendors, ensuring quality, timeliness, and regulatory defensibility of all deliverables.
- Champion implementation of automation, modern programming tools, and operational efficiencies to improve quality and execution speed across programs.
- Ensure all programming deliverables meet FDA and EMA eCTD submission requirements, including electronic Common Technical Document formatting standards.
Clinical Data Review and Development Decision Support
- Partner closely with Clinical Development Operations, Clinical Sciences, Medical Science, and Regulatory Affairs to interpret emerging clinical and biomarker data and inform program-level decisions.
- Present data analyses and strategic biometrics recommendations to C-suite leadership, Board of Directors, and external governance bodies.
Operational Excellence and Team Development
- Build and develop Kivu’s internal biometrics function, including hiring, mentorship, and performance development of biostatistics and programming staff.
- Drive accountability for external vendors and CRO partners; establish governance structures for vendor oversight and issue escalation.
- Implement scalable, milestone-driven processes supporting current late-stage programs and future pipeline growth.
- Maintain the highest standards of data integrity, quality, and regulatory defensibility across all programs.
- Ensure perpetual inspection readiness in compliance with FDA 21 CFR Part 11, GCP, and global expectations for advanced therapy submissions.
Education and Skill Requirements/Qualifications
- PhD in Biostatistics, Statistics, Mathematics, or a related quantitative PhD in Biostatistics, Statistics, Biometrics, or a related quantitative discipline.
- 15+ years of progressive experience in biostatistics and/or statistical programming in biopharmaceutical development, with at least 5 years in a senior leadership role.
- Demonstrated success leading biometrics activities supporting late-stage clinical development and regulatory submissions — including at least one BLA or NDA filing with FDA or equivalent global submission — with a strong record of successful health authority interactions.
- Deep expertise in oncology clinical development, including ADCs.
- Expert-level knowledge of GCP, ICH E9/E9(R1), ICH E6, CDISC standards (SDTM, ADaM, DEFINE-XML), and FDA/EMA regulatory expectations for advanced therapies.
- Demonstrated experience overseeing external statistical programming vendors and CROs in early and late-stage, submission-critical environment.
- Exceptional leadership, scientific communication, and cross-functional influencing skills; proven ability to operate effectively in a lean, agile biotechnology environment.
- Familiarity with FDA’s guidance framework for rare disease drug development, including Project Optimus, Accelerated Approval, Breakthrough Therapy Designation, and endpoint qualification processes.
- Experience supporting FDA advisory committee (AdCom) preparations and presentations.
- Prior experience operating as the senior biometrics’ leader within a small-to-mid-stage biotechnology company, including direct involvement in building or scaling an internal biometrics function.
Renumeration: Annual salary commensurate of experience and education training, full health benefits (medical, dental, vision), 401K contribution.
Kivu Bioscience, Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of an inclusive workforce. It is the Company’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Kivu Bioscience, Inc. maintains a drug-free workplace.