Manager Biostatistics Job at Confidential, Pasadena, CA

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  • Confidential
  • Pasadena, CA

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

Job Tags

Permanent employment, Full time, Relocation package,

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