Your Impact

Alpha-9 Oncology is seeking a Director/Senior Director, Biometrics to lead statistical strategy and execution across our early-phase clinical programs. As the first biostatistician at Alpha-9, you will establish the function, provide hands-on statistical support, and oversee CRO partners to ensure high-quality trial design, analysis, and reporting. This role offers the opportunity to shape the biostatics discipline in a growing, clinical stage radiopharmaceutical company with programs currently in Phase 0-1 trials.

How You’ll Contribute

• Serve as the lead statistician for Alpha-9’s early-phase trials, including study design, protocol development, statistical analysis plans, and data interpretation.
• Provide hands-on support for statistical programming and analysis to deliver timely, high-quality results for internal decision-making and regulatory submissions.
• Provide strategic oversight and cross-functional partnership on clinical data management activities, including database design input, data review, and ensuring analysis-ready datasets (SDTM/ADaM) to support interim and final analyses.
• Partner with Clinical Development, Regulatory, Data Management, and Operations to ensure statistical strategies are integrated into overall clinical trial execution.
• Author statistical sections of clinical protocols, SAPs, CSRs, and other regulatory documents to support IND/CTA submissions.
• Oversee CROs and external vendors to ensure statistical deliverables meet quality standards, timelines, and regulatory requirements.
• Implement and champion innovative statistical methodologies suitable for early-phase radiopharmaceutical studies, including adaptive and Bayesian designs.
• Establish scalable processes, standards, and best practices for biostatistics at Alpha-9, enabling future program expansion.
• Contribute to cross-functional discussions on trial design, safety monitoring, and data-driven decision-making.
  
  

The Skills You Bring

• Ph.D. with 10+ years or M.S. with 12+ years of experience as a biostatistician in biotech/pharma.
• Proven experience leading statistical design and analysis in early-phase clinical trials, ideally including oncology studies.
• Strong proficiency in statistical programming (SAS required; R or Python desirable) and familiarity with CDISC standards.
• Demonstrated ability to work effectively with CROs and external vendors in a lean biotechnology environment.
• Experience partnering closely with Clinical Data Management and vendors to support database build, data cleaning, and delivery of analysis-ready datasets (SDTM/ADaM).
• Knowledge of ICH/GCP guidelines and regulatory expectations for IND/CTA submissions.
• Excellent communication skills and collaboration skills, with ability to translate statistical concepts into actionable insights.