Manager Biostatistics

Manager / Sr. Manager, Biostatistics

Location: Pasadena, CA | Onsite

Full Time/Perm role

We are seeking an experienced Biostatistics Manager or Senior Manager to join a rapidly growing biopharmaceutical team developing RNAi-based therapeutics for diseases with strong genetic drivers. This role offers the opportunity to lead statistical strategy and execution across clinical programs driving innovative, life-changing treatments.

Key Responsibilities:

• Provide statistical expertise for clinical study design, analysis plans (SAP), and study reports (CSR).
• Partner cross-functionally with Clinical Development, Operations, and Regulatory teams to ensure statistical integrity of deliverables.
• Lead statistical analysis, data interpretation, and submission readiness.
• Oversee CRO deliverables, ensuring compliance with standards and timelines.
• Evaluate and implement innovative methodologies and best practices.

Qualifications:

• PhD (or MS with extensive experience) in Biostatistics or related field.
• 5+ years’ experience in pharma or biotech clinical development.
• Strong SAS and R programming skills; familiarity with East or nQuery preferred.
• Experience supporting regulatory submissions (FDA/EMA).
• Solid understanding of CDISC standards (SDTM/ADaM) and GCP.
• Excellent communication and leadership skills in cross-functional environments.

Preferred:

• Experience in pulmonary or genetic/rare disease therapeutic areas.
• Proven record in vendor oversight and project management.

Why Apply:

Join a science-driven, innovative environment where your biostatistics expertise directly advances therapies that can transform patient lives.

• Relocation Assistance
• Competitive Salary
• Stocks Unit