Director, Biostatistics

Kodiak Sciences; Palo Alto (CA); Sur place; USD 250 000 - 380 000; Plein temps

Résumé du poste

Kodiak Sciences in Palo Alto seeks a Director, Biostatistics to lead statistical strategy across clinical development and regulatory submissions. You will guide study design, SAPs, analysis plans, and CRO oversight, ensuring rigorous methods and regulatory readiness.

The ideal candidate has 10+ years in biostatistics within pharma/biotech/CRO, with proven leadership of cross-functional teams, strong regulatory communication, and CDISC proficiency. Ophthalmology experience is a plus.

Qualifications

• PhD or Master's degree in Biostatistics or related field.
• 10+ years in biostatistics within pharma/biotech/CRO, incl. late-phase trials.
• Proven leadership of cross-functional teams and complex programs.
• Strong knowledge of statistical methods for trials and CDISC standards.

Responsabilités

• Provide statistical leadership across clinical development programs and regulatory submissions.
• Oversee statistical deliverables from early phase through regulatory filing.
• Collaborate with Clinical, Regulatory, Data Management, and Medical Writing teams.
• Develop and review SAPs, CSRs, and regulatory filings (NDA, BLA, MAA).
• Represent Biostatistics in interactions with regulatory agencies.
• Manage external CROs/consultants for timely, high-quality support.
• Drive process improvements and adoption of best practices in analysis and visualization.
• Ensure compliance with ICH, GCP, FDA, EMA, and CDISC standards.

Connaissances

Biostatistics leadership

Clinical trial design

Regulatory submissions

Team leadership

SAS

R

CDISC SDTM/ADaM

ICH/GCP compliance

Regulatory interactions

Formation

PhD or MS in Biostatistics

Outils

SAS

R

Description du poste

We are seeking an experienced and strategic Director, Biostatistics to lead biostatistical support for 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 brings deep expertise in biostatistics, a collaborative approach, and proven experience leading cross-functional teams through global regulatory submissions.

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 preparation of responses and participation in meetings.
• 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 degree in Biostatistics, Statistics, or a related quantitative field.
• 10+ years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry, including experience 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.

About 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. Our ABC Platform uses molecular engineering to merge the fields of protein-based and chemistry-based therapies and has been at the core of Kodiak's discovery engine. We are developing a portfolio of three clinical programs, two of which are late-stage today and derived from our ABC Platform and one which is platform-independent and which we believe can progress rapidly into pivotal studies.