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.

Must Have:

• Ph.D or MS in Statistics or Biostatistics
• Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience
• Excellent knowledge of SAS computer package
• Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines
• Excellent organizational skills, time management, and ability to meet established deadlines
• Excellent communication and interpersonal skills to effectively interface with others
• Ability to work independently and problem-solve
• Ability to provide leadership for the CRO statisticians and statistical programmers