Senior Principal Biostatistician

Location: Paramus, NJ
Work Arrangement: Onsite
Job Type: Contract

A growing pharmaceutical organization is seeking an experienced Biostatistics leader to support clinical development programs from protocol design through final study reporting, regulatory submissions, and post-study analysis
. This role will lead key statistical activities across clinical trials and work closely with cross-functional teams, programmers, data management, and external partners to ensure high-quality statistical deliverables and timely execution.

Key Responsibilities

• Lead statistical support for clinical trials from protocol development through final study report
• Review study protocols and prepare statistical sections, including study design inputs, sample size calculations, analysis methods, and study duration assumptions
• Review CRFs, database design, and edit check specifications to support quality data collection
• Prepare and/or review Statistical Analysis Plans, TFL shells, and variable derivation specifications
• Partner with Statistical Programming and Clinical Data Management to identify and resolve data quality issues impacting key efficacy and safety endpoints
• Provide statistical review and validation support for analysis datasets, outputs, and tables/listings/figures
• Review study reports, manuscripts, and other scientific or regulatory documents with statistical content
• Support regulatory submissions by contributing statistical input and performing additional analyses requested by health authorities
• Monitor timelines and deliverables related to biostatistics and statistical programming
• Oversee CRO statistical activities and review vendor deliverables for quality and compliance
• Collaborate effectively with clinical, regulatory, data management, medical writing, and external vendor teams
• Perform additional statistical projects and ad hoc analyses as needed

Required Qualifications

• PhD in Statistics or Biostatistics with at least 4 years of pharmaceutical or CRO industry experience, or MS in Statistics/Biostatistics with at least 6 years of relevant industry experience
• Strong SAS programming knowledge
• Deep understanding of ICH guidelines, CDISC standards, and FDA regulatory expectations
• Hands-on experience with:
  • Protocol statistical review
  • Sample size calculation
  • SAP development
  • TFL shells and output specifications
  • CRF review
  • Database design review
  • Edit check specifications
  • Analysis dataset review and validation
  • Regulatory response support
  • CRO oversight
• Strong communication, organizational, and time management skills
• Ability to work independently while also leading cross-functional collaboration
• Proven ability to manage multiple priorities and meet aggressive deadlines

Preferred Background

• Experience supporting regulatory filings and health authority responses
• Experience contributing to drug development programs, study reports, and publication-related statistical content
• Ability to provide leadership and direction to CRO statisticians and statistical programmers

Core Competencies

• Strong analytical and problem-solving skills
• High attention to detail
• Ability to adapt quickly in a fast-paced clinical development environment
• Composed and effective under pressure
• Strong written and verbal communication skills

Ideal Candidate Profile
This opportunity is best suited for a statistician or biostatistician with strong clinical trial experience in pharma or CRO settings
, solid command of regulatory and industry standards
, and the ability to lead statistical strategy while partnering effectively across multiple functions.