Senior Director, Biostatistics

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Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

📋 Description

• Lead and coordinate statistical activities supporting the design, execution, analysis, interpretation, and reporting of clinical trials • Support statistical aspects of business-critical and regulatory commitments • Provide input to program plans • Represent Biostatistics on cross-functional and intra-departmental teams and working groups • Prepare or review clinical study protocols, case report forms, statistical analysis plans, and table shells • Create or validate SAS programs for data management, compliant analysis datasets, and statistical analysis of clinical trial data • Prepare statistical sections of clinical trial reports and present results to the team • Apply regulatory guidance and statistical methodology to clinical studies in pharmaceutical development • Write statistical reports and memos with minimal guidance • Validate complex datasets and summary tables • Prepare and document facts • Organize and maintain confidential project materials • Communicate with collaborators • Perform other duties as assigned

🎯 Requirements

• Master's Degree in statistics, biostatistics, or a closely related field • PhD preferred • 12+ years of clinical trials experience • At least 5 years of oncology clinical trials experience • Experience with solid tumor oncology preferred • Experience with global NDA/BLA submissions preferred • Experience designing, executing, and reporting Phase 3 oncology clinical trials as a lead statistician preferred • Strong knowledge of statistical software including SAS and R • Splus and SQL are a plus • Solid understanding of regulatory guidance and statistical methodology in pharmaceutical development • Ability to write and articulate clearly • Ability to prioritize workload and meet multiple delivery timelines • Excellent planning and organization skills • Excellent problem-solving abilities • Ability to function independently and exercise judgment and decision-making skills • Continuous improvement mindset • Flexible and willing to learn and adapt to business and site needs • Positive, approachable, and professional attitude

🏖️ Benefits

• Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays