Reporting to the EVP, Clinical Development, the Vice President of Biostatistics will provide strategic and operation leadership for all biostatistics activities across the company's development portfolio. This individual will play a critical role in advancing clinical programs and supporting global regulatory submissions and approvals. The VP will oversee statistical strategy, trial design, and data interpretation across multiple programs, with a strong focus on lung and prostate cancer indications. This leader will work cross-functionally with Clinical Development, Data Management, Clinical Operations, Medical Affairs, and Regulatory Affairs, to ensure seamless execution, data driven decision making, and robust, high-quality data generation aligned with global health authorities expectations. This role requires deep expertise in statistical methodologies, strong scientific judgment, and the ability to anticipate what is required to advance complex clinical programs in a dynamic environment. The ideal candidate will balance scientific rigor with operational excellence, and communicate effectively with executive leaders, scientific teams, regulators, and external partners. The VP will also be instrumental in enhancing organizational capability and fostering a high-performing, collaborative culture aligned with our values. Job Description 3 Lead the overall biostatistics strategy across all clinical development programs, from early development through registration and post-marketing activities. 3 Provide statistical leadership for the design and execution of Phase 3 clinical trials, including innovative trial design and methodology (eg, adaptive designs and modeling approaches), endpoint selection, and sample size determination. 3 Oversee the development of statistical analysis plans (SAPs) and contribute to the development of clinical study reports (CSRs) and regulatory submission documents. 3 Lead data interpretation and support decision-making at key program milestones, including interim analyses and final data readouts. 3 Serve as the biostatistics lead in interactions with external data monitoring committees and global health authorities. 3 Oversee CROs, data vendors, and technology platforms to ensure high-quality deliverables, on-time execution, and compliance with regulatory and industry standards. 3 Champion modern data management and statistical computing practices, ensuring infrastructure supports scale, audit readiness, and efficiency. 3 Stay abreast of emerging statistical methodologies, regulatory trends, and industry best practices to ensure the organization remains at the forefront of scientific and statistical innovation. 3 Lead and mentor a high-performing biostatistics team, including internal staff and external vendors/CRO partners. Qualifications 3 PhD or master's degree in Biostatistics, Statistics, or related field. 3 15+ years of relevant experience in biotech/pharmaceutical R&D. 3 Late stage development experience. in particular in Oncology, is strongly preferred. 3 At least 7 years leading Biostatistics teams, including management of statisticians, programmers, and/or data management groups. 3 Demonstrated success in shaping statistical strategy for pivotal trials and regulatory submissions. 3 Proven ability to influence senior stakeholders, navigate ambiguity, and drive alignment across cross-functional teams. 3 Strong track record of contributing to late-stage development/regulatory submissions with NDA experience strongly preferred. 3 Deep understanding of global regulatory guidelines, data requirements, clinical operations interfaces, and inspection readiness. 3 Exceptional communication skills with ability to translate complex statistical concepts into clear, actionable insights for diverse audiences. 3 Experience managing departmental budgets, vendor relationships, and technical infrastructure. 3 Highly collaborative, with strong interpersonal skills and the ability to build trust across teams. 3 Strategic thinker with strong scientific rigor and operational pragmatism. 3 Thrives in a fast-paced, evolving environment; able to manage multiple priorities with clarity and focus. 3 Demonstrates integrity, accountability, and a commitment to continuous learning and team development. 3 Comfortable with hands-on leadership in a small-company environment. Additional Information The anticipated base salary for candidates who will work on-site at our San Diego location is between $320,000-$350,000 per year. The final rate offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors. This position is not eligible for H-1B visa sponsorship.