Director, Biostatistics

Job Title: Director, Biostatistics

Location: Remote

Position Summary:

We are seeking a Director of Biostatistics who will report to the Executive Director of Biostatistics. You will focus on contributing to efforts across multiple studies, analyzing and reporting on any or all parts of clinical studies. The Director will have oversight of statistical programming and deliverables that contribute to the quality assurance and control of statistical analyses, writing methods and analysis descriptions in formal reports, communicating with collaborators, and organizing and maintaining confidential project materials.

Responsibilities:

Lead and coordinate statistical related activities to support clinical studies including but not limited to supporting the design, execution, analysis, interpretation, and reporting of clinical trials as well as communication of data evidence.

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 as needed.

Create or validate SAS programs for data management activities, compliant analysis datasets, and statistical analysis of the 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.

Qualifications:

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.

About Us:

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth.

Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going.

Celcuity is an Equal-Opportunity Employer.

Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $230,000 - $260,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.

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We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

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