Director Biostatistics

Kodiak Sciences; Palo Alto (CA); On-site; USD 225,000 - 240,000; Full time

Job summary

Kodiak Sciences is seeking an Associate Director of Business Operations to lead biostatistical support within clinical development programs. This key role involves strategic oversight, ensuring data integrity and regulatory compliance, while collaborating with cross-functional teams to drive excellence in clinical trials. The ideal candidate must hold a PhD or Master’s in a relevant field, with over 10 years of industry experience.

Qualifications

• 10+ years of experience in biostatistics within the biopharmaceutical industry.
• Proven experience leading teams and managing complex clinical development programs.
• Ophthalmology experience preferred.

Responsibilities

• Provide statistical leadership across clinical development programs and regulatory submissions.
• Ensure compliance with industry and regulatory standards.
• Oversee statistical deliverables for clinical trials.

Skills

Statistical methodology

Data integrity

Regulatory compliance

Project management

Leadership

Education

PhD or Master’s in Biostatistics, Statistics, or related field

Tools

SAS

R

Job description

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Associate Director, Business Operations at Kodiak Sciences

Kodiak Sciences is a biopharmaceutical company committed to researching, developing, and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases. We are focused on bringing new science to the design and manufacture of next-generation retinal medicines to prevent and treat the leading causes of blindness globally.

We are seeking an experienced and strategic Director, Biostatistics to lead biostatistical support across our 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). This role is on-site at Kodiak's headquarters in Palo Alto, CA.

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.

Education & Qualifications

• 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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

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