Senior Principal Biostatistician
hace 3 días
Paramus
Job Description 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, • 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, • Experience supporting regulatory filings and health authority responses, • Experience contributing to drug development programs, study reports, and publication-related statistical content, • 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