Sr. Director / Executive Director, BiostatisticsReporting to the VP of Biometrics, the Senior Director / Executive Director, Biostatistics will lead the Biostatistics function, providing strategic leadership and operational oversight across ALX Oncology's clinical development programs. This individual will play a key role in shaping oncology development strategies, influencing critical program decisions, and ensuring the quality and timely execution of statistical activities from early development through registration.
The successful candidate will bring deep expertise in oncology drug development, including late-stage registrational trials, and biomarker-driven strategies. Working closely with cross-functional leaders, this individual will translate complex statistical considerations into actionable recommendations while maintaining accountability for statistical deliverables, external partners, and functional resources. This role requires someone equally comfortable operating at the strategic level and engaging directly in the technical and operational aspects of clinical development.
Preference will be given to applicants who can regularly work onsite Mondays and Tuesdays as part of the company's hybrid work model. Applicants who are authorized to work in the U.S. without sponsorship are encouraged to apply.
Key Responsibilities include: - 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 that support 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 deep oncology expertise to address complex statistical challenges and support biomarker-driven development, precision medicine, and companion diagnostic (CDx) strategies.
- Lead statistical contributions to global regulatory interactions and submissions, including FDA and EMA meetings, regulatory briefing packages, and NDA/BLA submissions.
- Oversee the development and delivery of statistical analysis plans (SAPs), analysis datasets, tables, listings, and figures (TLFs), clinical study reports (CSRs), 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 closely with Statistical Programming, Data Management, and other functions to ensure effective execution.
- Provide technical leadership and mentorship to statistical resources while partnering with senior leadership on functional capabilities, resource planning, and organizational priorities.
- Support other Biometrics and organizational priorities as needed.
- Contribute to a culture that reflects ALX Oncology's values by acting with integrity, accountability, transparency, and respect. Build strong, collaborative relationships through active engagement with colleagues, including regular onsite participation consistent with the company's hybrid work model.
Not sure if you are qualified for this position? We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants. You are encouraged to apply even if you do not meet each of the list preferred qualifications.Preferred Qualifications include: - PhD in Biostatistics, Statistics, or a related quantitative discipline with a minimum of 12 years of relevant biotechnology or pharmaceutical industry experience; or MS with a minimum of 15 years of relevant experience.
- Extensive experience in oncology drug development, including the 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, influencing clinical development plans, study designs, regulatory strategies, and critical program decisions.
- Demonstrated 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 (CDx) 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.
- Proactively explores emerging technologies, including AI and automation, and identifies practical opportunities to improve the efficiency, quality, and scalability of the Biostatistics function.
- Strong leadership, communication, and collaboration skills, with the ability to influence cross-functional teams and senior management in a dynamic environment.
CompensationThis role can be based at our South San Francisco, CA corporate office (preferred) or remote-based. The salary range for this position in South San Francisco is $300,000-$330,000. The position may be filled at either the Sr. Director or Executive Director level, depending on the candidate's qualifications. For remote-based candidates, the salary range will be based on the applicable geographic market, which varies state to state and is typically lower than the San Francisco Bay Area. Actual compensation will be determined based on factors including position level, academic credentials, specialized clinical expertise and relevant experience.
In addition to a competitive market-based salary, ALX Oncology offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package including 401K. Additional information can be found here: https://alxoncology.com/careers/
