Vice President, Biostatistics

Posted 17 Days Ago
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San Diego, CA, USA
Hybrid
320K-350K Annually
Expert/Leader
Biotech • Pharmaceutical
The Role
Leads biostatistics strategy across clinical development programs, including Phase 3 trial design, statistical analysis plans, data interpretation, regulatory submissions, and health authority interactions. Oversees CROs, vendors, statistical infrastructure, and compliance while mentoring internal and external teams. Partners cross-functionally to support oncology programs, pivotal trials, inspection readiness, and data-driven decision-making.
Summary Generated by Built In
Company 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.

Skills Required

  • PhD or master's degree in Biostatistics, Statistics, or a related field
  • 15+ years of relevant experience in biotech or pharmaceutical R&D
  • Late-stage development experience, particularly in oncology
  • At least 7 years leading biostatistics teams, including statisticians, programmers, and/or data management groups
  • Success shaping statistical strategy for pivotal trials and regulatory submissions
  • Ability to influence senior stakeholders, navigate ambiguity, and drive cross-functional alignment
  • Experience contributing to late-stage development and regulatory submissions; NDA experience
  • Deep understanding of global regulatory guidelines, data requirements, clinical operations interfaces, and inspection readiness
  • Exceptional communication skills and ability to explain complex statistical concepts clearly
  • Experience managing departmental budgets, vendor relationships, and technical infrastructure
  • Strong collaboration, interpersonal, trust-building, strategic thinking, scientific rigor, and operational pragmatism
  • Ability to work in a fast-paced, evolving environment and manage multiple priorities
  • Integrity, accountability, continuous learning, and commitment to team development
  • Comfort with hands-on leadership in a small-company environment
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The Company
HQ: South San Francisco, CA
Year Founded: 2014

What We Do

ORIC Pharmaceuticals is a clinical-stage biopharmaceutical company focused on overcoming resistance in cancer. It develops precision medicines intended to make existing cancer therapies more effective and durable. Its clinical-stage candidates include rinzimetostat (ORIC-944), an EED/PRC2 inhibitor being developed for prostate cancer, and enozertinib, a brain-penetrant inhibitor targeting EGFR and HER2 exon 20 and EGFR atypical mutations across genetically defined cancers, alongside additional resistance-focused medicines.

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