Job Summary
Kodiak Sciences Inc., a leading biopharmaceutical company dedicated to advancing treatments for retinal diseases, is hiring a Director of Biostatistics at their Palo Alto, CA headquarters. This pivotal leadership role offers the opportunity to shape statistical strategy and execution across global clinical development programs and regulatory submissions. Ideal for a senior biostatistics professional with 10+ years of industry experience, this position demands expertise in late-phase clinical trials, statistical methodology, and regulatory engagement with FDA, EMA, and other agencies.
Key Responsibilities
Provide strategic statistical leadership across all phases of clinical development programs.
Lead study design, protocol development, and creation of Statistical Analysis Plans (SAPs).
Oversee statistical deliverables from early to late-phase trials and regulatory filings.
Collaborate with Clinical, Regulatory, Data Management, and Medical Writing teams.
Develop and review SAPs, clinical study reports, NDAs, BLAs, and MAAs.
Represent Biostatistics in regulatory agency interactions, including FDA and EMA meetings.
Manage external CROs/consultants for statistical services and deliverables.
Drive process innovation and implement best practices in statistical analysis and data visualization.
Ensure strict adherence to industry and regulatory standards such as ICH, GCP, FDA, EMA, and CDISC.
Required Skills & Qualifications
PhD or Master’s degree in Biostatistics, Statistics, or related quantitative discipline.
Minimum 10 years of experience in biostatistics within pharma, biotech, or CRO environments.
Expertise in late-phase clinical trials and global regulatory submissions.
Proven track record of leading statistical teams and cross-functional clinical development programs.
Strong understanding of statistical methods, CDISC (SDTM, ADaM), and regulatory guidelines.
Proficiency in SAS and R statistical software.
Excellent communication, leadership, and project management capabilities.
Experience with regulatory body interactions (FDA, EMA) highly preferred.
Ophthalmology therapeutic area experience preferred but not mandatory.
Perks & Benefits
Competitive salary package (exact range not disclosed).
Opportunity to lead statistical strategy for high-impact clinical programs.
Work in an innovative and science-driven biopharmaceutical company.
Collaborative cross-functional environment.
Exposure to global regulatory agency interactions and high-stakes submissions.
Company Description
Kodiak Sciences Inc. is a cutting-edge biopharmaceutical company revolutionizing the treatment of retinal diseases worldwide. Focused on developing next-generation medicines, Kodiak leverages scientific innovation to prevent and manage the leading causes of blindness.
Work Mode
On-site (Palo Alto, CA, USA)
Call to Action
Are you an experienced biostatistics leader ready to drive clinical trial excellence and regulatory success? Apply now to join Kodiak Sciences as Director, Biostatistics and contribute to life-changing retinal therapies.
Salary/Compensation Range: Competitive (Not specified).
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