Job Summary
Kodiak Sciences Inc. is seeking an experienced and strategic Director, Biostatistics to provide leadership and oversight for its clinical development programs in Palo Alto, CA. This pivotal role involves steering biostatistical support across all phases of clinical trials, ensuring adherence to rigorous statistical methodologies, regulatory guidelines, and data integrity. The ideal candidate possesses advanced expertise in biostatistics for drug development, particularly in regulatory submissions such as NDA, BLA, and MAA, and demonstrates strong cross-functional collaboration with clinical, medical writing, and regulatory teams.
Key Responsibilities
Lead statistical strategy and execution for global clinical development programs.
Develop and review study designs, protocols, and Statistical Analysis Plans (SAPs).
Oversee statistical analysis and deliverables from early-phase to late-stage trials.
Ensure accurate, regulatory-compliant statistical documentation for submissions (NDA, BLA, MAA).
Represent Biostatistics during interactions with global regulatory agencies (FDA, EMA).
Collaborate with Clinical, Regulatory, Data Management, and Medical Writing teams.
Manage external CROs and consultants to ensure timely, high-quality statistical services.
Drive innovation and process improvements in statistical methodology and data visualization.
Guarantee adherence to industry guidelines including ICH, GCP, FDA, EMA, and CDISC.
Required Skills & Qualifications
PhD or Master’s degree in Biostatistics, Statistics, or a related field.
Minimum 10+ years of biostatistics experience in pharma, biotech, or CRO industries.
Strong background in late-phase clinical trials and regulatory submissions.
Expertise in CDISC standards (SDTM, ADaM).
Proficiency in statistical programming (SAS, R).
Excellent leadership, communication, and project management abilities.
Experience with global regulatory bodies such as the FDA and EMA.
Prior exposure to ophthalmology trials (preferred).
Perks & Benefits
Competitive salary package (not specified in the job description).
Opportunity to lead biostatistical efforts in cutting-edge retinal disease therapeutics.
Work with a pioneering biopharmaceutical company shaping the future of ophthalmology treatments.
Collaborative and innovative workplace culture at Kodiak’s Palo Alto headquarters.
Company Description
Kodiak Sciences Inc. is a leading biopharmaceutical company specializing in novel therapeutics for retinal diseases, dedicated to combating the world’s leading causes of blindness. Focused on breakthrough science and advanced manufacturing, Kodiak is redefining retinal medicine for global impact.
Work Mode
On-site (Palo Alto, CA, USA)
Call to Action
Are you an expert in clinical biostatistics with a passion for transforming retinal disease therapeutics? Apply now to join Kodiak Sciences and lead the statistical strategy behind life-changing biopharmaceutical innovations.
Salary/Compensation Range: Not disclosed
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Kyiv |Lima Region :
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