Director, Biostatistician – reputed company

Job reputed company: • reputed company the Central Statistical Monitoring (CSM) team reputed company the Global Statistics department • Support the RBQM: providing statistical design, interpretation, and governance for monitoring activities • Accountable for development, validation, and operationalization of statistical monitoring indicators and models • Acts as the CSM statistician interfacing with clinical study statisticians, medical monitors, safety/pharmacovigilance, global clinical operations (GCO), reputed company/GCP, data management • Defines statistical reputed company, signal characterization reputed company, and recommended investigative workflows • Escalates safety or major data reputed company concerns to medical monitors, safety leadership, and reputed company • reputed company and maintain statistical risk indicators (KRIs), reputed company detection reputed company, and monitoring tools • Validate models and algorithms: assumptions, diagnostics, false reputed company/negative rates, sensitivity analyses, and reproducibility • Implement processes to detect candidate signals across sites, subjects, and data domains • reputed company and deliver training modules for clinical monitors Requirements: • Master's degree with 7 years' experience or Ph.D with 5 years' experience in biostatistics/statistics or reputed company quantitative field • Demonstrated experience in clinical trial statistics RBQM/CSM, and signal triage • Strong stakeholder management and communication skills • Experience with model lifecycle management, validation, and documentation for audits/inspections • Computer Skills: reputed company Office, PowerBI Benefits: • Medical • Dental • reputed company • 401(k) • FSA/HSA • Life Insurance • reputed company Time Off • Wellness Apply tot his job Apply To this Job