Director, Biostatistics

Job Title

Director, Biostatistics

Remote

We are seeking a Director of Biostatistics who will report to the Executive Director of Biostatistics. The Director will focus on contributing to efforts across multiple studies, analyzing and reporting on any or all parts of clinical studies. The role includes 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.

• Lead and coordinate statistical related activities to support clinical studies including design, execution, analysis, interpretation, and reporting of clinical trials and communication of data evidence.
• Support the statistical aspects of business-critical and/or regulatory commitments, provide input to program plans, and represent 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 present results to the team.
• Demonstrate solid understanding of regulatory guidance and statistical methodology as applied to clinical studies in pharmaceutical development.
• Write statistical reports and memos with minimal guidance.
• Validate complex datasets or summary tables.
• Prepare and document facts to enable management to write and support trial reports and publications.
• Other duties as assigned.

• Master's Degree in statistics, biostatistics or a closely related field;
  PhD preferred.
• 10+ years clinical trials experience with at least 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; S‑plus and SQL are plus.
• Excellent written and verbal communication skills.
• 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; seeks ways to drive innovation and efficiencies.
• Flexible and willing to learn; adapts to business and site needs in a dynamic environment.
• Maintain a positive, approachable and professional attitude.

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.

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 a variety of benefits including medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.