Kodiak Sciences
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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 Referrals increase your chances of interviewing at Kodiak Sciences by 2x Sign in to set job alerts for “Director Biostatistics” roles.
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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 Referrals increase your chances of interviewing at Kodiak Sciences by 2x Sign in to set job alerts for “Director Biostatistics” roles.
South San Francisco, CA $260,687.00-$322,025.00 1 month ago Palo Alto, CA $225,000.00-$240,000.00 1 month ago San Francisco Bay Area $236,000.00-$295,000.00 18 hours ago San Francisco Bay Area $200,000.00-$230,000.00 3 weeks ago San Francisco Bay Area $1.00-$2.00 1 month ago San Francisco Bay Area $185,000.00-$267,000.00 2 weeks ago San Francisco Bay Area $320,000.00-$380,000.00 16 hours ago Alameda, CA $187,500.00-$266,000.00 1 day ago Menlo Park, CA $253,000.00-$314,000.00 2 weeks ago Director of Biostatistics, Translational
Redwood City, CA $230,000.00-$255,000.00 1 week ago Director of Finance and Administration, Biomedical Data Science
Stanford, CA $205,050.00-$283,688.00 7 months ago South San Francisco, CA $275,000.00-$336,000.00 2 weeks ago Palo Alto, CA $220,000.00-$270,000.00 14 hours ago South San Francisco, CA $260,687.00-$322,025.00 3 weeks ago Director of Data Science - Recommendations and E-Commerce
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Fremont, CA $320,000.00-$380,000.00 2 days ago Director, Clinical Development, Hematology/Oncology (Remote)
Director, Early Clinical Development (MD), Autoimmune Cell Therapy
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr