Sr. Director / Executive Director, Biostatistics

ALX Oncology Inc.•South San Francisco, CA

3h•$300,000 - $330,000•Hybrid

About The Position

Reporting to the VP of Biometrics, the Senior Director / Executive Director, Biostatistics will lead the Biostatistics function and provide strategic leadership and operational oversight across ALX Oncology’s clinical development programs. The role shapes oncology development strategies, influences critical program decisions, and ensures high-quality, timely statistical activities from early development through registration. The successful candidate brings deep expertise in oncology drug development, including late-stage registrational trials and biomarker-driven strategies, and can translate complex statistical considerations into actionable recommendations while maintaining accountability for statistical deliverables, external partners, and functional resources. The role combines strategic leadership with direct engagement in technical and operational aspects of clinical development. The position may be based at the South San Francisco corporate office, which is preferred, or remotely. The company’s hybrid work model favors applicants able to work onsite Mondays and Tuesdays regularly. The position may be filled at either the Senior Director or Executive Director level, depending on qualifications. Applicants authorized to work in the U.S. without sponsorship are encouraged to apply.

Requirements

PhD in Biostatistics, Statistics, or a related quantitative discipline and at least 12 years of relevant biotechnology or pharmaceutical industry experience, or an MS and at least 15 years of relevant experience.
Extensive oncology drug-development experience, including design, analysis, and interpretation of early- and late-phase clinical trials, with demonstrated leadership in Phase 3 registrational studies.
Proven ability to provide strategic statistical leadership and influence clinical development plans, study designs, regulatory strategies, and critical program decisions.
Experience leading a Biostatistics function or major clinical development programs, balancing strategic leadership with hands-on operational execution.
Deep knowledge of oncology clinical trial methodology, including survival analysis, time-to-event endpoints, estimands, multiplicity adjustment, and interim analyses.
Strong experience with innovative clinical trial designs and statistical methodologies, including adaptive designs, Bayesian approaches, and simulation-based methods.
Experience with biomarker-driven development and companion diagnostic strategies, including relevant statistical and regulatory considerations.
Significant experience supporting global regulatory interactions and submissions, including direct engagement with FDA, EMA, and other health authorities.
Strong knowledge of ICH guidelines, GCP, and industry data standards, including CDISC, SDTM, and ADaM.
Strong technical proficiency in SAS and R, with the ability to critically evaluate analyses and provide hands-on statistical expertise when needed.
Demonstrated ability to manage CROs, external consultants, and statistical programming resources, ensuring quality, accountability, and timely execution.
Strong leadership, communication, and collaboration skills, with the ability to influence cross-functional teams and senior management in a dynamic environment.

Nice To Haves

Proactively explores emerging technologies, including AI and automation, and identifies practical opportunities to improve the efficiency, quality, and scalability of the Biostatistics function.

Responsibilities

Provide strategic statistical leadership across early- and late-stage oncology clinical development programs, influencing study design, regulatory strategy, and critical program decisions.
Lead the Biostatistics function, setting priorities, managing resources, and ensuring high-quality, timely execution of statistical activities across clinical programs.
Partner with Clinical Development, Regulatory Affairs, and other cross-functional leaders to develop statistical strategies supporting scientific, regulatory, and business objectives.
Lead statistical strategy and design for Phase 1–3 oncology trials, particularly late-stage registrational studies, including endpoint selection, estimands, sample size determination, and data interpretation.
Evaluate and recommend innovative clinical trial designs, including adaptive, basket, and umbrella trials, and advanced statistical methodologies such as Bayesian and simulation-based approaches.
Apply oncology expertise to complex statistical challenges and support biomarker-driven development, precision medicine, and companion diagnostic strategies.
Lead statistical contributions to global regulatory interactions and submissions, including FDA and EMA meetings, regulatory briefing packages, and NDA/BLA submissions.
Oversee development and delivery of statistical analysis plans, analysis datasets, tables, listings and figures, clinical study reports, and regulatory submissions.
Provide hands-on statistical expertise as needed, including complex analyses, modeling, simulation, and resolution of technical challenges.
Direct and oversee CROs, statistical consultants, and external partners, ensuring quality, accountability, and adherence to timelines and budgets.
Establish and maintain Biostatistics processes, SOPs, and quality standards, working with Statistical Programming, Data Management, and other functions to ensure effective execution.
Provide technical leadership and mentorship to statistical resources and partner with senior leadership on functional capabilities, resource planning, and organizational priorities.
Support other Biometrics and organizational priorities as needed.
Contribute to a culture reflecting ALX Oncology’s values of integrity, accountability, transparency, and respect, and build collaborative relationships through active engagement, including regular onsite participation consistent with the hybrid work model.