Director Biostatistics

Position Summary:

We are seeking an experienced and visionary 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.

Key Responsibilities:

• Provide statistical input into study design, protocol development, clinical trial analysis plans (SAPs), and regulatory submissions.
• Serve as the statistical representative in cross-functional project teams and interactions with regulatory agencies (e.g., FDA, EMA).
• Ensure high-quality statistical deliverables including statistical analysis plans, mock shells, tables/listings/figures, clinical study reports (CSRs), and regulatory submission packages.
• 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.
• Develop and implement statistical methodologies aligned with evolving industry practices and regulatory expectations.
• Lead or support statistical aspects of Health Authority meetings, responses to queries, and advisory committee preparation.
• Contribute to statistical innovation through exploration of adaptive designs, Bayesian approaches, or real-world data integration, as appropriate.

Qualifications:

• PhD (or MS 3 additional years) in Biostatistics, Statistics, or a related field.
• Minimum of 10 years (Director) or 12 years (Senior Director) of relevant experience in biostatistics in the pharmaceutical, biotechnology, or CRO industry.
• Proven track record of leading statistical strategy and execution in clinical trials, including successful regulatory submissions.
• Strong knowledge of regulatory requirements and guidance documents (e.g., ICH E9/E10, FDA, EMA).
• Hands-on experience with statistical software packages (e.g., SAS, R).
• Excellent communication and interpersonal skills; able to translate complex statistical concepts into clear messages for non-statistical audiences.
• Strategic mindset with a pragmatic and collaborative approach to problem-solving.

Preferred Qualifications:

• Industry experience with ophthalmology.
• Prior participation in regulatory advisory meetings (e.g., End-of-Phase, Pre-NDA/BLA, Advisory Committee).