Director, Biostatistics

Job not on LinkedIn

November 9

❄️ Minnesota – Remote

Although this job is listed in Minnesota, this company may be open to hiring remote in other states.

💵 $230k - $260k / year

⏰ Full Time

🔴 Lead

👔 Director

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Celcuity

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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.

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Lead and coordinate statistical related activities to support clinical studies including design, execution, analysis, interpretation, and reporting of clinical trials • Support for the statistical aspects of business-critical and/or regulatory commitments, provides input to program plans, and represents the Biostatistics function for cross-functional and intra-departmental teams or working groups • Prepare or review the 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 the statistical section of clinical trial reports and presentations of the results to the team • Demonstrate solid understanding of regulatory guidance and statistical methodology as applied to clinical studies in pharmaceutical development • Writing statistical reports and memos with minimal guidance • Validating complex datasets or summary tables • Prepares and documents facts to enable management to write and support trial reports and publications • Other duties as assigned.

🎯 Requirements

• Master's Degree in statistics, biostatistics or a closely related field; PhD preferred • Ten plus (10+) years clinical trials experience with at least three (3) years in oncology clinical trials • Experience with solid tumor oncology and NDA/BLA submission preferred • Strong knowledge of statistical software packages including SAS and R • Other statistical analysis and reporting applications such as Splus and SQL are plus • Ability to write and articulate clearly • Strong sense of urgency and commitment to excellence in the successful achievement of defined project objectives • 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; seeking ways to drive innovation and efficiencies throughout the organization • Flexible and willing to learn; adapting to business and site needs in a dynamic environment • Maintain a positive, approachable and professional attitude.

🏖️ Benefits

• medical insurance • dental insurance • vision insurance • 401(k) match • PTO • paid holidays