[Hiring] Senior Biostatistician @ACL Digital

Role Description

Our biotechnology client is seeking an experienced Consultant Biostatistician to independently lead statistical support for early-phase oncology clinical studies and upcoming IND programs. This individual will serve as the lead Study Statistician for assigned trials, partnering closely with cross-functional teams to drive study execution, interpret clinical data, and provide strategic statistical guidance throughout the development process. This role is best suited for someone who thrives in a lean, fast-paced biotech environment, enjoys wearing multiple hats, and can operate with minimal oversight while serving as a trusted scientific partner.

Key Responsibilities

• Serve as the lead Study Statistician for assigned early-phase oncology clinical trials.
• Provide statistical leadership from study start-up through study completion, including protocol development, Statistical Analysis Plans (SAPs), analysis, interpretation, and reporting.
• Partner closely with Clinical Development, Clinical Operations, Data Management, Medical Monitoring, Programming, and other cross-functional stakeholders.
• Proactively monitor study conduct, identify potential risks or data trends, and recommend appropriate actions.
• Support Safety Review Committee meetings by preparing statistical analyses and providing recommendations related to emerging safety data and dose escalation decisions.
• Interpret clinical trial data and communicate findings to support study and development decisions.
• Contribute to IND-enabling activities and other regulatory deliverables as needed.
• Provide strategic statistical consultation and act as a collaborative advisor to study teams.
• Effectively manage priorities across multiple studies while maintaining high-quality deliverables.

Qualifications

• MS or PhD in Biostatistics, Statistics and 8-10+ years of experience.
• Must have experience working in a small biotech or pharma company.
• Demonstrated experience serving as the lead Study Statistician for oncology clinical trials.
• Strong experience supporting early-phase clinical development (Phase I/II), including IND-enabling studies.
• Comprehensive knowledge of clinical trial design, statistical methodologies, and regulatory requirements.
• Ability to independently manage studies with minimal direction or supervision.
• Excellent verbal and written communication skills with the ability to explain statistical concepts to cross-functional teams.
• Proven ability to build strong collaborative relationships and serve as a trusted scientific partner.
• Experience working within small or emerging biotechnology companies.
• Experience supporting Safety Review Committees and dose escalation decisions.
• Prior experience contributing to IND submissions.
• Ability to thrive in a dynamic, entrepreneurial environment where flexibility and initiative are essential.

Requirements

• 10+ years of work experience with Biostatistics.
• 6+ years of work experience with Oncology.
• Master's Degree.
• 8+ years of Pharmaceutical Manufacturing experience.