Job Description
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