Senior Biostatistician

Job Description :

No 3rd party corp candidates

On-Site - Candidates must be local to Palo Alto

We are seeking an experienced and strategic Senior Biostatistician to lead biostatistical support across our clinical development programs and regulatory submissions. This 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).

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

$110-$115 hourly W2 / $135-$140 hourly 1099, commensurate with experience