<p>Position Summary:</p> <p>We are seeking an experienced and visionary Director or Senior Director of Biostatistics to lead statistical strategy and execution of clinical trials. The successful candidate will play a key leadership role in designing and analyzing clinical trials. This position requires a strong combination of technical expertise, strategic thinking, and cross functional collaboration.</p> <p>Key Responsibilities:</p> <ul> <li>Provide statistical input into study design, protocol development, clinical trial analysis plans (SAPs), and regulatory submissions. </li><li>Serve as the statistical representative in cross-functional project teams and interactions with regulatory agencies (e.g., FDA, EMA). </li><li>Ensure high-quality statistical deliverables including statistical analysis plans, mock shells, tables/listings/figures, clinical study reports (CSRs), and regulatory submission packages. </li><li>Collaborate closely with clinical developments, clinical operations, medical writing, regulatory affairs, data management, and programming teams to ensure alignment of statistical activities with overall clinical objectives. </li><li>Develop and implement statistical methodologies aligned with evolving industry practices and regulatory expectations. </li><li>Lead or support statistical aspects of Health Authority meetings, responses to queries, and advisory committee preparation. </li><li>Contribute to statistical innovation through exploration of adaptive designs, Bayesian approaches, or real-world data integration, as appropriate. </li></ul> <p>Qualifications:</p> <ul> <li>PhD (or MS+3 additional years) in Biostatistics, Statistics, or a related field. </li><li>Minimum of 10+ years (Director) or 12+ years (Senior Director) of relevant experience in biostatistics in the pharmaceutical, biotechnology, or CRO industry. </li><li>Proven track record of leading statistical strategy and execution in clinical trials, including successful regulatory submissions. </li><li>Strong knowledge of regulatory requirements and guidance documents (e.g., ICH E9/E10, FDA, EMA). </li><li>Hands-on experience with statistical software packages (e.g., SAS, R). </li><li>Excellent communication and interpersonal skills; able to translate complex statistical concepts into clear messages for non-statistical audiences. </li><li>Strategic mindset with a pragmatic and collaborative approach to problem-solving. </li></ul> <p>Preferred Qualifications:</p> <ul> <li>Industry experience with ophthalmology. </li><li>Prior participation in regulatory advisory meetings (e.g., End-of-Phase, Pre-NDA/BLA, Advisory Committee). </li></ul>