Confidential
Manager / Sr. Manager, Biostatistics
Confidential, Pasadena, California, United States, 91122
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. Benefits
Relocation Assistance Stocks Unit Vision insurance Medical insurance Seniority level
Mid‑Senior level Employment type
Full‑time Job function
Research Industries
Biotechnology Research, Health and Human Services, and Pharmaceutical Manufacturing Location & Salary
Santa Monica, CA | $153,935.00‑$219,120.00
#J-18808-Ljbffr
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. Benefits
Relocation Assistance Stocks Unit Vision insurance Medical insurance Seniority level
Mid‑Senior level Employment type
Full‑time Job function
Research Industries
Biotechnology Research, Health and Human Services, and Pharmaceutical Manufacturing Location & Salary
Santa Monica, CA | $153,935.00‑$219,120.00
#J-18808-Ljbffr