Executive Director, Biostatistics – Oncology Strategy

ALX Oncology Inc.; South San Francisco (CA); Hybrid; USD 300,000 - 330,000; Full time

Benefits offered by this job

Stock options

Performance-based bonus

Benefits package including 401K

Job summary

ALX Oncology Inc. is seeking a Senior Director/Executive Director of Biostatistics to lead the Biostatistics function across clinical development programs.

The role combines strategic leadership with hands-on technical and operational contributions to ensure timely, high-quality statistical deliverables. The candidate will guide design and analysis for Phase 1-3 oncology trials, integrate biomarker-driven strategies, and manage CROs and external partners while engaging with regulatory

Qualifications

• PhD in Biostatistics, Statistics, or related field with 12+ years biotech/pharma industry experience; or MS with 15+ years experience.
• Extensive oncology drug development experience, including late-stage trials and leadership in Phase 3.
• Proven ability to lead a Biostatistics function and influence clinical development plans.
• Strong knowledge of oncology trial methodology and regulatory considerations.
• Experience with biomarker-driven development and CDx strategies.
• Experience with regulatory interactions (FDA/EMA) and CDISC data standards.

Responsibilities

• Provide strategic statistical leadership across early- and late-stage oncology programs.
• Lead Biostatistics function, set priorities, manage resources, ensure timely execution.
• Partner with cross-functional teams to develop statistical strategies aligned with objectives.
• Lead statistical design for Phase 1-3 oncology trials, including estimands and sample size.
• Evaluate innovative trial designs (adaptive, basket, umbrella) and Bayesian methods.
• Lead biomarker-driven development and companion diagnostics considerations.
• Support regulatory submissions and interactions with agencies.
• Oversee SAPs, TLFs, CSRs, and regulatory submissions; ensure quality and timelines.
• Mentor statistical staff and manage CROs/external partners.

Skills

Biostatistics leadership

Oncology drug development

Regulatory strategy

Bayesian methods

Adaptive designs

SAS

R

CRO management

AI in statistics

Cross-functional collaboration

Education

PhD in Biostatistics

MS with 15+ years experience

Tools

SAS

R

Job description

ALX Oncology Inc. is seeking a Senior Director/Executive Director of Biostatistics to lead the Biostatistics function across clinical development programs.

The role combines strategic leadership with hands-on technical and operational contributions to ensure timely, high-quality statistical deliverables. The candidate will guide design and analysis for Phase 1-3 oncology trials, integrate biomarker-driven strategies, and manage CROs and external partners while engaging with regulatory