The Senior Director, Biostatistics provides strategic statistical leadership across ALX Oncology's clinical development portfolio, partnering cross-functionally to design, execute, analyze, and interpret clinical studies that support regulatory submissions and advance innovative oncology therapies. This role drives statistical strategy, oversees outsourced biostatistics activities, and collaborates closely with Clinical Development, Translational Medicine, Biomarker Sciences, Regulatory Affairs, Data Management, Statistical Programming, Clinical Operations, and external partners.

 

Preference will be given to candidates who can regularly work onsite Mondays and Tuesdays as part of the company's hybrid work model.

 

Key Responsibilities include:

  • Lead the Biostatistics function by developing and executing strategies that support ALX Oncology's clinical development portfolio, providing strategic leadership across oncology programs from early development through registration and lifecycle management.
  • Direct statistical strategy for registrational clinical trials, including innovative adaptive and biomarker-driven study designs, and provide expertise in study design, endpoint selection, estimands, multiplicity control, interim analyses, missing data, sensitivity analyses, and benefit-risk assessments.
  • Oversee the development, review, and approval of key statistical deliverables, including protocols, statistical analysis plans (SAPs), clinical study reports (CSRs), regulatory briefing documents, publications, and scientific presentations.
  • Drive adaptive design evaluations and statistical simulations to support study design, operating characteristics, power calculations, and informed decision-making throughout clinical development.
  • Provide statistical leadership for global regulatory interactions, health authority submissions, companion diagnostic (CDx) and biomarker-driven development programs, partnering closely with cross-functional teams to ensure compliance with applicable regulatory requirements and industry standards.
  • Oversee CROs, external statistical vendors, budgets, and outsourced Biostatistics activities, ensuring high-quality deliverables, effective governance, and operational excellence.
  • Provide technical leadership and mentorship across the Biometrics organization, fostering collaboration, innovation, and the adoption of statistical best practices.
  • Contribute to business development, due diligence, portfolio strategy, and other strategic initiatives as needed.
  • Contribute to a culture that reflects ALX'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.

 

Preferred Qualifications include:

  • Bachelor's degree in Statistics, Biostatistics, Mathematics, Life Sciences, Computer Science, or a related quantitative discipline, or an equivalent combination of education and directly relevant work experience. Advanced degree (MS, PhD, or equivalent) in a quantitative discipline is strongly preferred.
  • Approximately 12+ years of progressive Biostatistics experience within biotechnology, pharmaceutical, or CRO environments, including Phase I-III oncology clinical studies, with demonstrated success leading statistical strategy for registrational clinical trials, partnering across cross-functional teams, and supporting global regulatory submissions.
  • Experience with companion diagnostic (CDx) co-development, biomarker-driven development strategies, and interactions with global health authorities.
  • Deep expertise in biostatistical principles, oncology clinical trial methodology, GCP, applicable regulatory requirements, and industry best practices including study design, adaptive clinical trial methodologies, survival analysis, estimands, multiplicity adjustment, missing data methodology, interim analyses, and companion diagnostic statistical approaches.
  • Proficiency with statistical programming and analysis software, including SAS and R. Experience with adaptive design and simulation software (e.g., EAST, ADDPLAN, or equivalent).
  • Strategic, collaborative leader with excellent communication, organizational, and relationship-building skills, capable of influencing cross-functional teams and external partners.
  • Demonstrated ability to prioritize competing demands, solve complex problems, build scalable processes, and adapt to evolving business priorities while contributing beyond functional boundaries in a fast-paced, resource-constrained environment.

 

Compensation

The salary range for this position at our South San Francisco, CA corporate office is $240,000 - $280,000. Additional factors such as academic credentials and relevant experience will influence the actual salary offered. 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/

 

About ALX Oncology

ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action. A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.

 

Information for Recruitment Agencies

Please note that ALX Oncology does not accept unsolicited resumes or candidate information from recruitment agencies, including blinded or anonymized resumes, and will not be responsible for any fees associated with unsolicited submissions.  Do not contact hiring managers or other ALX Oncology employees directly. Recruiting activities are managed through our Human Resources team.