Senior Director, Biometrics

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Establish and lead a premier Biometrics department, attracting, developing, and retaining top talent in Biostatistics, and Statistical Programming.
• Actively engage in the design and analysis of clinical trials and preclinical studies.
• Lead cross-functional initiatives to advance clinical development and regulatory success.
• Develop and implement statistical analysis plans, including hands-on statistical programming and data analysis as needed.
• Collaborates closely with Clinical Development and Operations, Regulatory Affairs, Biomarkers, and Data Management teams to ensure robust study designs and accurate data interpretation.
• Foster synergies between functional areas to support the efficient development of high-quality study deliverables.
• Provide statistical input and support for regulatory submissions and interactions with health authorities.
• Ensures the statistical integrity of protocols, statistical analysis plans, clinical study reports, presentations, and publications of clinical trial data.
• Work with internal and external stakeholders in the design, collection, analysis, reporting, interpretation, and publication of clinical trial data.
• Set the strategic direction for the Biometrics department, aligning goals with organizational objectives and long-term growth; develop budgets, set priorities, ensure consistency and adherence to standards, and create departmental SOPs.
• Drive the development and implementation of new innovations, standards, processes, and programming efficiencies across biometrics.
• Maintain a broad understanding of relevant external trends, anticipates emerging issues, identifies strategic needs in technical knowledge, and sets the strategic direction to meet regulatory, scientific, and business needs.
• Oversee CRO biometrics deliverables, including but not limited to database and CRF development, statistical analysis plans, and interim and final TLF deliverables, ensuring quality and alignment with organizational goals and      objectives.
• Represents the organization at professional societies, external scientific forums, and industry-wide technical discussions, as applicable.
• Ensure the statistical integrity of all deliverables and compliance with regulatory requirements.
• Lead quality assurance initiatives and corrective action planning.
• Provide expertise and consultation as a subject matter expert to project teams and serves as a key point of contact with senior management to continuously assess and improve operational project delivery.
• Monitor the qualitative and quantitative progress of biometrics implementation activities; oversees study reporting and tracks key indicators for performance and progress evaluation.
• Ensure consistent use of study tools, training materials, and compliance with standard processes, policies, and procedures.
• Other duties as assigned or deemed necessary by management.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

• Ph.D. or Master’s degree in Biostatistics, Statistics, or a related field.
• Minimum of 10 years of experience in biostatistics within biotech or pharmaceutical environments, with 5+ years in a senior leadership role.
• Demonstrated success in leading biometrics teams through all phases of drug development, including regulatory submissions and health authority interactions.
• Strong Phase III statistical planning background.
• Proven track record of strategic planning, innovation, and cross-functional leadership.
• Expertise in statistical software (e.g., SAS, R), data management tools, EDC platforms, and CDISC standards.
• Strong executive presence, communication, and interpersonal skills.
• Ability to influence and collaborate at all levels of the organization.