Lead Biostatistician

- Provide strategic statistical guidance on study design, including statistical model selection, sample size calculations, and analysis planning across clinical trials and non-interventional studies (NIS). - Lead the development and programming of statistical analyses, tables, figures, and listings (TFLs) using SAS, ensuring alignment with sponsor requirements and internal standards. - Generate and validate derived analysis datasets in compliance with CDISC ADaM standards. - Author, review, and ensure rigorous quality control (QC) of Statistical Analysis Plans (SAPs) and related statistical documentation. - Validate programming output (e.g., TFLs, datasets) generated by team members to ensure accuracy and consistency. - Provide expert statistical input to study documents, including Case Report Forms (CRFs), Data Management Plans (DMPs), and clinical protocols. - Oversee and ensure proper execution of randomization procedures. - Conduct and interpret meta-analyses using statistical results from multiple published studies, ensuring scientifically robust conclusions. - Lead the statistical review and interpretation of Clinical Study Reports (CSRs), ensuring alignment with the SAP and regulatory expectations. - Proactively prioritize and manage multiple studies and projects to meet timelines and client expectations, balancing resources and risk. - Serve as a primary statistical point of contact for internal and external stakeholders, providing clear, compliant, and insightful responses and guidance. - Ensure all statistical deliverables meet applicable regulatory standards (e.g., ICH, GCP), industry guidelines, and internal SOPs. - Foster and maintain trusted relationships with clients, leading communication on statistical matters and contributing to long-term collaboration. - Drive the continuous improvement and development of internal statistical programming practices, guidelines, and SOPs. - Mentor junior team members, contribute to training initiatives, and promote a high-performing, quality-focused team culture. - Serve as a domain expert, integrating clinical, statistical, and industry best practices to design tailored solutions for complex client needs. - Collaborate with cross-functional teams to deliver innovative, high-impact statistical strategies that align with client objectives.