Sr. Director, Biostatistics

ALX Oncology Inc.•South San Francisco, CA

3d•$240,000 - $280,000

About The Position

We are seeking an experienced and strategic Senior director of Biostatistics to provide statistical leadership across oncology clinical development programs, with strong expertise in Phase 3 registrational studies, adaptive clinical trial design, and companion diagnostic (CDx) development. The successful candidate will play a critical role in advancing precision medicine strategies through innovative trial methodologies, biomarker-driven development, and global regulatory engagement. This position requires extensive experience in oncology drug development, late-stage clinical trial strategy, adaptive designs, biomarker and CDx co-development, and regulatory submissions. The Senior Director will collaborate closely with Clinical Development, Translational Medicine, Biomarker Sciences, Regulatory Affairs, Data Management, Statistical Programming, Clinical Operations, and external partners.

Requirements

PhD or MS in Biostatistics, Statistics, or related quantitative discipline.
PhD with 12+ years of biotechnology/pharmaceutical industry experience, or MS with 15+ years of industry experience.
Extensive oncology drug development experience required.
Demonstrated leadership in Phase 3 registrational oncology trials.
Strong experience with adaptive clinical trial designs and simulation methodologies.
Experience supporting companion diagnostic (CDx) co-development programs and biomarker-driven development strategies.
Prior experience with global regulatory submissions and health authority interactions required.
Strong knowledge of oncology clinical trial methodology, survival analysis and time-to-event endpoints, multiplicity adjustment and alpha control, group sequential and adaptive methodologies, Bayesian and frequentist approaches, biomarker-driven clinical development, estimands framework, missing data methodology, interim monitoring and IDMC support, and companion diagnostic statistical methodologies.
Proficiency in SAS.
Proficiency in R.
Strategic and innovative thinker with strong scientific judgment.
Excellent communication and influencing skills.
Ability to explain complex statistical concepts to technical and non-technical stakeholders.
Strong collaboration and stakeholder management capabilities.
Proven ability to lead in a fast-paced biotechnology environment.

Nice To Haves

PhD strongly preferred.
Biotech industry experience strongly preferred.
EAST, ADDPLAN, or similar adaptive design software preferred.
Immuno-oncology and targeted therapy development.
Companion diagnostic (CDx) co-development and PMA support.
Precision medicine and biomarker-enriched development programs.
Global multi-regional clinical trials.
Accelerated approval pathways.

Responsibilities

Provide strategic statistical leadership for oncology programs from early development through registration and lifecycle management.
Lead statistical design and execution of Phase 1–3 oncology clinical trials, with substantial emphasis on registrational Phase 3 studies.
Develop innovative and efficient clinical trial designs, including adaptive designs, biomarker-enrichment strategies, basket, umbrella, and platform trials.
Provide statistical guidance on endpoint selection and multiplicity control, estimand strategy, missing data methodology, and sensitivity analyses.
Contribute to clinical development plans, protocols, statistical analysis plans (SAPs), clinical study reports (CSRs), regulatory briefing packages, publications and scientific presentations.
Lead development and evaluation of adaptive design methodologies using simulation-based approaches.
Conduct or oversee statistical simulations evaluating operating characteristics, Type I error control, statistical power, futility and efficacy boundaries, and adaptive enrichment strategies.
Partner with programming teams to develop simulation frameworks in R and/or SAS.
Communicate complex adaptive design concepts effectively to cross-functional teams and regulatory agencies.
Lead statistical support for End-of-Phase 2 meetings or Type B meetings, scientific advice meetings, and NDA/BLA submissions.
Provide strategic input on alpha allocation/multiplicity adjustment, interim/final data analyses, IDMC/DMC support, and benefit-risk assessments.
Ensure compliance with ICH, FDA, EMA, and global regulatory guidance for both therapeutics and diagnostics.
Function as a core member of oncology program teams.
Mentor and provide technical leadership to statisticians and programmers.
Oversee CROs and external statistical vendors.
Drive adoption of statistical standards, innovative methodologies, and data quality best practices.
Support business development, due diligence, and portfolio strategy activities.