Alpha-9 Oncology · 1 day ago
Director/Senior Director, Biometrics
Boston, Massachusetts, United States
Full-time
Onsite
Director/Executive
$213K/yr - $288K/yr
10+ years expAlpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. They are seeking a Director/Senior Director of Biostatics to lead statistical strategy and execution across early-phase clinical programs, providing hands-on statistical support and overseeing CRO partners.
BiotechnologyHealthcareMedicalProduct Research
Responsibilities
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
Qualification
Required
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
Benefits
Annual performance bonus
Participation in our equity incentive plan
Comprehensive benefits package
Company
Alpha-9 Oncology
Alpha-9 Oncology is a biopharma company that focuses on radiotherapeutics for the treatment of solid and hematologic malignancies.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$259.02MKey Investors
Ascenta Capital,Lightspeed Venture PartnersNextech InvestLongitude Capital
2024-10-23Series C· $175M
2022-12-14Series B· $75M
2021-04-28Series A· $8.94M
Leadership Team
Robert Meehan
Chief Medical Officer
Recent News
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