Senior Director, Biostatistics

Celcuity

Senior Director leading biostatistics for Celcuity, a biotechnology company developing targeted therapies for solid tumors. Overseeing oncology trial design, analysis, reporting, and regulatory deliverables.

Posted 8/13/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $245,000 - $255,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in leading statistical activities for clinical trials, with a strong focus on oncology and regulatory compliance. Proficient in SAS and R for data management and analysis, with a solid understanding of statistical methodology in pharmaceutical development.

Highest-signal resume keywords

Clinical Trials ExperienceOncology Clinical TrialsSAS ProgrammingStatistical AnalysisRegulatory Guidance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisClinical Trial DesignData ManagementStatistical ReportingStatistical MethodologySAS ProgrammingR ProgrammingSQLPhase 3 TrialsNDA/BLA Submissions

Soft Skills

Problem-SolvingCommunicationPlanning and OrganizationDecision-MakingAdaptability

Certifications & Qualifications

Master's Degree in StatisticsPhD in Statistics or Biostatistics

Industry Keywords

BiostatisticsPharmaceutical DevelopmentOncologyClinical Study ProtocolsCase Report Forms

Tech Stack

Tools & technologies

SQL

About the role

Key responsibilities & impact

Lead and coordinate statistical activities supporting the design, execution, analysis, interpretation, and reporting of clinical trials
Support statistical aspects of business-critical and regulatory commitments
Provide input to program plans
Represent Biostatistics on cross-functional and intra-departmental teams and 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, 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 and summary tables
Prepare and document facts
Organize and maintain confidential project materials
Communicate with collaborators
Perform other duties as assigned

Requirements

What you’ll need

Master's Degree in statistics, biostatistics, or a closely related field
PhD preferred
12+ years of clinical trials experience
At least 5 years of oncology clinical trials experience
Experience with solid tumor oncology preferred
Experience with global NDA/BLA submissions preferred
Experience designing, executing, and reporting Phase 3 oncology clinical trials as a lead statistician preferred
Strong knowledge of statistical software including SAS and R
Splus and SQL are a plus
Solid understanding of regulatory guidance and statistical methodology in pharmaceutical development
Ability to write and articulate clearly
Ability to prioritize workload and 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 and adapt to business and site needs
Positive, approachable, and professional attitude

Benefits

Comp & perks

Annual performance incentive bonus
New hire equity package
Medical insurance
Dental insurance
Vision insurance
401(k) match
PTO
Paid holidays