• The Head of Biometrics will be responsible for the strategic positioning and tactical advancement of Biostatistics and Data Management. • This role will be accountable for all Biostatistics technical plans and analyses, Data Management functions, Statistical Programming functions, and Clinical Systems. • Define and execute the strategic vision for the Biometrics Department. • Establish organizational structure for the Biometrics Department, including Statistical Programming, Data Management, and Clinical Systems functions. Lead and develop Biometrics employees. • Oversee and coordinate and be directly responsible for all biostatistics activities to support clinical development projects, delivering study designs and analysis plans, ensuring sound biostatistics principles and compliance with regulatory guidelines. • Advise on statistical issues associated with the design and analysis of clinical trials and provide biostatistics input on all major documents, including clinical development plans, protocols, data collection methodologies, statistical analysis plans, clinical study reports, and summaries of clinical safety and efficacy for regulatory filings. • Guide the application of epidemiologic methods to analyze observational/real-world data to calculate appropriate sample sizes, strengthen submission evidence and support drug development. • Provide review and guidance on statistical aspects, new programming, database technologies, clinical systems, and standards of all FDA/EMEA regulations and ICH & GCP guidelines. • Serve as the senior biostatistics representative supporting protocol/clinical document review, strategic and partner joint development activities, drug safety, and publication activities. • Collaborate with other senior development leaders to ensure consistency of development work standards, intellectually challenging assumptions, and sharing ideas. • Provide leadership for sponsor/CRO activities, relationships, and escalation resolution. • Interact as required with FDA/EMA and other health authorities to ensure clinical studies meet regulatory requirements and ensure ongoing agreement on project development. • Support the development and implementation of best practices, SOPs, standards, work instructions, and policies for biostatistics.