Job Description

Job Title: Associate Director / Director, Biostatistics

Location: Alameda, CA OR King of Prussia, PA (Comprehensive Relocation Package Available)

Type: Full-Time (Bonuses/RSU options)

Overview:

We are hiring for both Associate Director and Director-level Biostatistics roles to support clinical development across all phases. This is a high-impact opportunity to lead study-level strategy, oversee CROs, and drive statistical deliverables in a collaborative and innovative environment. Oncology experience is highly preferred.

Key Responsibilities:

• Provide strategic and technical leadership on clinical trial design, analysis, and reporting
• Author and review statistical analysis plans, TLF shells, and ADaM specifications
• Oversee statistical deliverables and programming activities across one or more studies
• Partner cross-functionally with clinicians, data managers, programmers, and medical writers
• Manage CROs to ensure quality, timelines, and compliance with regulatory standards
• Support submission activities and publication development
• Ensure adherence to ICH, GCP, and FDA/EMA regulatory requirements

Qualifications:

• PhD with 5+ years
• Strong background in SAS programming and statistical methodology
• Proven experience with SDTM/ADaM, regulatory submissions, and CRO oversight
• Oncology and early-to-late phase study experience highly desirable
• Excellent communication and cross-functional leadership skills

Why Join:

• Lead high-visibility programs with strategic impact
• Collaborate with a high-performing, science-driven team
• Competitive compensation and relocation assistance offered

Ready to make a difference? Apply today!

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