Director, Biostatistics

Celcuity Inc.; Northern (KY); Hybrid; USD 195,000 - 215,000; Full time

Benefits offered by this job

Annual incentive bonus

Equity package

Medical, dental, vision insurance

401(k) match

PTO and paid holidays

Job summary

Celcuity Inc. is seeking a Director of Biostatistics to lead statistical activities across multiple oncology studies. You will oversee statistical programming, write methods and analysis descriptions, and communicate results with collaborators while maintaining confidential materials.

Ideal candidates have a PhD (preferred) with 7+ years in clinical trials, including 2+ years in oncology. Expect collaboration across global submissions and a competitive compensation package.

Qualifications

• Master's degree in statistics/biostatistics; PhD preferred.
• 7+ years clinical trials experience, at least 2 years in oncology.
• Solid tumor oncology experience and NDA/BLA submissions preferred.
• Experience with design, execution, and reporting phase 3 oncology trials as lead statistician preferred.
• Strong knowledge of SAS and R; SQL scripting is a plus.

Responsibilities

• Lead and coordinate statistical activities to support clinical studies, including design, execution, analysis and reporting.
• Provide input to program plans and represent Biostatistics in cross-functional teams.
• Prepare or review protocols, CRFs, SAPs, and table shells.
• Create or validate SAS programs for data management and analysis.
• Prepare statistical sections of reports and present results to team.
• Oversight of CROs on statistical deliverables.
• Maintain confidential project materials.

Skills

Statistical programming

Strong writing

Prioritization

Communication

Education

Master's degree in statistics/biostatistics

PhD preferred

Tools

SAS

R

S-Plus

SQL

Job description

Reporting to the Vice President, Biostatistics and Data Management, the Director, Biostatistics will focus on actively contributing to efforts across multiple studies, analyzing and reporting on any or all parts of clinical studies. The role 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.
• Oversight CRO on statistical deliverables
• Other duties as assigned.

Qualifications:

• Master's Degree in statistics, biostatistics or a closely related field; PhD preferred.
• 7+ years clinical trials experience with 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. 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 Celcuity:

Celcuity is a commercial biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting.

The Phase 3 VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and either fulvestrant or letrozole for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer. A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing.

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 $195,000 to $215,000 DOE. 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.