VP, Biostatistics — Oncology Clinical Development

ORIC Pharmaceuticals, Inc.; San Diego (CA); Hybrid; USD 320.000 - 350.000; Vollzeit

Zusammenfassung

ORIC Pharmaceuticals, Inc. in San Diego is seeking a Vice President of Biostatistics to lead statistical strategy and oversee Phase 3 design and regulatory submissions across the portfolio.

You will supervise SAPs, CSRs, and data interpretation while collaborating with Clinical Development, Data Management, Regulatory Affairs, and Medical Affairs to ensure robust, compliant data generation and timely decisions.

Qualifikationen

• PhD or Master’s degree in Biostatistics, Statistics, or related field.
• 15+ years of relevant biotech/pharmaceutical R&D experience.
• Late stage development experience, oncology preferred.
• 7+ years leading biostatistics teams, including management of statisticians and data management groups.
• Strong track record in regulatory submissions and NDA experience preferred.

Aufgaben

• Lead biostatistics strategy across all clinical programs from early development through registration and post-marketing.
• Provide statistical leadership for Phase 3 design, adaptive designs, endpoint selection, and sample size determinations.
• Oversee SAP development and contribute to CSRs and regulatory submission documents.
• Lead data interpretation and support decision-making at key program milestones.
• Serve as biostatistics lead in interactions with external data monitoring committees and health authorities.
• Oversee CROs and data vendors to ensure high-quality, compliant deliverables.

Kenntnisse

Leadership

Regulatory submissions

Statistical strategy

Cross-functional collaboration

Budget management

Ausbildung

PhD or Master’s in Biostatistics

Jobbeschreibung

ORIC Pharmaceuticals, Inc. in San Diego is seeking a Vice President of Biostatistics to lead statistical strategy and oversee Phase 3 design and regulatory submissions across the portfolio.

You will supervise SAPs, CSRs, and data interpretation while collaborating with Clinical Development, Data Management, Regulatory Affairs, and Medical Affairs to ensure robust, compliant data generation and timely decisions.