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Our client is a biopharmaceutical company committed to researching, developing, and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases. Focusing on bringing new science to the design and manufacture of next-generation retinal medicines to prevent and treat the leading causes of blindness globally, this role is on-site at the company’s headquarters in Palo Alto, CA, so local candidates are preferred. The organization’s three lead product candidates are in Phase III with BLAs to follow in the near term, so there is a key opportunity here to play an integral role in submission activity.

Currently they are seeking an experienced and strategic Director/Senior Director, Biostatistics to lead biostatistical support across clinical development programs and regulatory submissions. This leadership role will provide scientific and operational oversight across all phases of clinical trials, ensuring rigorous statistical methodology, data integrity, and regulatory compliance. The ideal candidate is both technically strong and a collaborative leader, with a proven track record of guiding cross-functional teams through global regulatory engagements (e.g., FDA, EMA). (The level of the role will depend on experience.)

Key Responsibilities

• Provide statistical leadership across clinical development programs, including study design, protocol development, SAP creation, and analysis planning.
• Oversee statistical deliverables for clinical trials from early phase through late-stage development and regulatory submission.
• Partner with Clinical, Regulatory, Data Management, and Medical Writing teams to ensure statistically sound study design and high-quality deliverables.
• Lead the development and review of key documents, including statistical analysis plans, clinical study reports, and regulatory filings (e.g., NDA, BLA, MAA).
• Represent biostatistics in interactions with regulatory agencies, including preparing responses and meeting participation.
• Manage external CROs/consultants to ensure on-time, high-quality statistical support and deliverables.
• Drive process improvements, innovation, and adoption of best practices in statistical analysis and data visualization.
• Ensure compliance with industry and regulatory standards, including ICH, GCP, FDA, EMA, and CDISC.

Please have:

• PhD or Master's in Biostatistics, Statistics, or a related quantitative field.
• 10+ years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry, including expertise in late-phase clinical trials and regulatory submissions.
• Proven experience leading teams and managing complex clinical development programs.
• Strong knowledge of statistical methods for clinical trials, regulatory guidelines, and CDISC standards (SDTM, ADaM).
• Proficiency in statistical software (e.g., SAS, R).
• Excellent communication, leadership, and project management skills.
• Experience with global regulatory interactions and submissions preferred.
• Ophthalmology experience preferred.

This is a visible role in a smaller organization where you will have the opportunity to have real impact in this meaningful field.