Vice President, Biostatistics

ORIC Pharmaceuticals Inc.; San Diego (CA); On-site; USD 320,000 - 350,000; Full time

Job summary

ORIC Pharmaceuticals, Inc. in San Diego, CA, seeks a VP of Biostatistics to lead statistical strategy across all clinical programs, from development through regulatory submissions.

This on-site role requires expertise in trial design, data interpretation, and governance, with a focus on oncology and cross-functional collaboration with Clinical Development, Regulatory Affairs, and external partners. You will mentor a high-performing biostatistics team, oversee SAPs/CSRs, manage CROs and vendors,

Qualifications

• PhD or master's degree in Biostatistics or related field.
• Minimum 15 years of biotech/pharmaceutical R&D experience.
• Late-stage development experience, oncology preferred.
• 7+ years leading Biostatistics teams.
• Experience with regulatory submissions (NDA) a plus.

Responsibilities

• Lead the overall biostatistics strategy across all clinical development programs.
• Provide statistical leadership for Phase 3 trial design, endpoints, and sample size.
• Develop SAPs and contribute to CSRs and regulatory submissions.
• Oversee data interpretation and program milestones decisions.
• Collaborate with external data monitoring committees and health authorities.
• Manage CROs, data vendors, and tech platforms for quality and compliance.
• Champion modern data management and scalable statistical computing.
• Stay updated on methodologies and regulatory trends.
• Mentor a high-performing biostatistics team, including vendors.

Skills

Biostatistics leadership

Communication skills

Statistical methodology

Strategic thinking

Regulatory submissions

Education

PhD in Biostatistics

Master's degree in Biostatistics

Tools

SAS

R

CDISC

Job description

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn.

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

• Lead the overall biostatistics strategy across all clinical development programs, from early development through registration and post-marketing activities.
• 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.
• Oversee the development of statistical analysis plans (SAPs) and contribute to the development of clinical study reports (CSRs) and regulatory submission documents.
• Lead data interpretation and support decision-making at key program milestones, including interim analyses and final data readouts.
• Serve as the biostatistics lead in interactions with external data monitoring committees and global health authorities.
• Oversee CROs, data vendors, and technology platforms to ensure high-quality deliverables, on-time execution, and compliance with regulatory and industry standards.
• Champion modern data management and statistical computing practices, ensuring infrastructure supports scale, audit readiness, and efficiency.
• 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.
• Lead and mentor a high-performing biostatistics team, including internal staff and external vendors/CRO partners.

Qualifications

• PhD or master's degree in Biostatistics, Statistics, or related field.
• 15+ years of relevant experience in biotech/pharmaceutical R&D.
• Late stage development experience. in particular in Oncology, is strongly preferred.
• At least 7 years leading Biostatistics teams, including management of statisticians, programmers, and/or data management groups.
• Demonstrated success in shaping statistical strategy for pivotal trials and regulatory submissions.
• Proven ability to influence senior stakeholders, navigate ambiguity, and drive alignment across cross-functional teams.
• Strong track record of contributing to late-stage development/regulatory submissions with NDA experience strongly preferred.
• Deep understanding of global regulatory guidelines, data requirements, clinical operations interfaces, and inspection readiness.
• Exceptional communication skills with ability to translate complex statistical concepts into clear, actionable insights for diverse audiences.
• Experience managing departmental budgets, vendor relationships, and technical infrastructure.
• Highly collaborative, with strong interpersonal skills and the ability to build trust across teams.
• Strategic thinker with strong scientific rigor and operational pragmatism.
• Thrives in a fast-paced, evolving environment; able to manage multiple priorities with clarity and focus.
• Demonstrates integrity, accountability, and a commitment to continuous learning and team development.
• 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.

ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.