Senior Principal Biostatistician

GLOBAL Recruitment Solutions•Paramus, NJ

1d•Onsite

About The Position

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.

Requirements

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
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

Nice To Haves

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

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