Director, Biostatistics

🔥 1 hour ago

🇺🇸 United States – Remote

💵 $195k - $215k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 3%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 clinical studies • Support the design, execution, analysis, interpretation, and reporting of clinical trials • Communicate data evidence • Support statistical aspects of business-critical and regulatory commitments • Provide input to program plans • Represent Biostatistics in cross-functional and intra-departmental teams or 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 activities, 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 or summary tables • Oversee CRO statistical deliverables • Organize and maintain confidential project materials • Perform other duties as assigned

🎯 Requirements

• Master's Degree in statistics, biostatistics or a closely related field • 7+ years clinical trials experience • At least 2 years in oncology clinical trials • Experience with solid tumor oncology and global NDA/BLA submissions preferred • Experience with design, execution, and reporting phase 3 oncology clinical trials as a lead statistician preferred • Strong knowledge of statistical software packages including SAS and R • Splus and SQL are a plus • Ability to write and articulate clearly • Strong sense of urgency and commitment to excellence • Ability to prioritize workload to 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; adapting to business and site needs in a dynamic environment • Maintain a 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