Senior Biostatistician

Senior Biostatistician

Requirements

• Master’s or Ph.D. in Statistics, Biostatistics, Health Informatics or related field
• 5+ years of experience in healthcare data analysis, biostatistics and clinical research
• Proficiency in SQL, Python, R, and other statistical software (SPSS, SAS)
• Experience with data visualization tools (Power BI, Tableau)
• Strong understanding of healthcare terminology, EHR systems, and data standards (HL7, FHIR)
• Excellent analytical, problem-solving, and communication skills

Responsibilities

• Develop statistical analysis plans for MRI-based studies, ensuring scientific rigor and compliance with regulatory guidelines (FDA, EMA, ICH E9)
• Design and implement appropriate statistical models for longitudinal, cross-sectional, and case-control studies involving whole-body MRI data
• Perform sample size calculations and power analyses specific to imaging-based endpoints
• Conduct inferential statistical analyses (e.g., mixed-effects models, logistic regression, Cox proportional hazards models) to evaluate the association between imaging biomarkers and clinical outcomes
• Evaluate the reliability, reproducibility, and clinical validity of imaging-derived metrics through methods such as intra-class correlation coefficients (ICC), Bland-Altman plots, and variance component analysis
• Lead quantitative analysis of whole-body MRI-derived biomarkers, including organ volumetry, fat fraction analysis, muscle composition, and vascular measurements
• Organize, assess, clean, and validate imaging data, ensuring data quality and compliance with research and business objectives
• Implement missing data imputation techniques and conduct sensitivity analyses to enhance the robustness of imaging-based findings
• Provide statistical justifications for imaging-derived primary and secondary endpoints in regulatory submissions
• Collaborate with medical writers and clinicians to prepare peer-reviewed publications, abstracts, and conference presentations
• Communicate complex statistical concepts to non-technical stakeholders, translating technical results into actionable insights for clinical research, regulatory discussions, and business strategies
• Design and develop reports and dashboards using tools like SQL, Power BI, and Tableau for real-time clinical trial monitoring and imaging study analysis
• Ensure data accuracy, reliability, and integrity through rigorous quality assurance protocols
• Develop and maintain documentation, including Data Management Plans (DMPs) and electronic Case Report Form (eCRF) specifications
• Collaborate with database programmers to design (e)CRFs and perform User Acceptance Testing (UAT)

Preferred Qualifications

• Experience in medical coding and healthcare data standards and regulatory authorities procedures (e.g. FDA)
• Knowledge of AI/ML dataset management
• Prior experience with clinical trial data and publication in peer-reviewed journals
• Proficient in diagnostic performance analysis to evaluate the effectiveness of AI models in medical imaging and diagnostics
• Skilled in designing and implementing risk assessment models that utilize clinical and imaging data to quantify patient risk profiles
• Experienced in conducting cost-effectiveness analyses to assess the economic value of screening and diagnostic tests