Director/Senior Director, Biometrics

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.

Company Summary

Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.

Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.

More about Alpha-9 Oncology

Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.

We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.