Director, Biostatistics — Clinical Trials & Submissions

Kodiak Sciences; Palo Alto (CA); Vor Ort; USD 250.000 - 380.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Biostatistics leadership

Clinical trial design

Regulatory submissions

Team leadership

SAS

R

CDISC SDTM/ADaM

ICH/GCP compliance

Regulatory interactions

Ausbildung

PhD or MS in Biostatistics

Tools

SAS

R

Jobbeschreibung

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.