Senior Manager Biostatistics

Location: Hybrid (NJ 3x a week) Industry: Biopharmaceutical / Clinical Development Senior Manager, Biostatistics A growth‑stage biopharmaceutical organization is seeking a Senior Manager, Biostatistics to play a key role in advancing clinical development programs across multiple therapeutic areas. This individual will contribute to the design, analysis, and interpretation of clinical studies, partnering closely with cross‑functional stakeholders to drive data‑driven decision‑making throughout the product lifecycle. Key Responsibilities Provide statistical leadership across one or more clinical programs, ensuring quality and consistency of deliverables Contribute to protocol development and study design , including endpoint selection and statistical methodologies Author and review statistical analysis plans (SAPs) Lead the analysis and interpretation of clinical trial and real‑world data to support regulatory and clinical evidence generation Oversee statistical activities across the study lifecycle, from development through clinical study report (CSR) delivery and publication Collaborate cross‑functionally with Clinical, Data Management, Medical Affairs, Regulatory, and CRO partners Review and approve statistical outputs produced internally and by external partners, ensuring regulatory compliance and quality standards Support regulatory interactions , including briefing materials and responses to health authority requests Identify risks and contribute to mitigation strategies related to statistical design and analysis Qualifications Education & Experience PhD in Biostatistics, Statistics, or related discipline with ~4+ years of industry experience OR Master's degree with ~6+ years of experience in pharma/biotech environments Demonstrated experience leading statistical components of clinical trial design, analysis, and reporting Technical & Functional Expertise Strong understanding of clinical trial design methodologies , including adaptive designs Hands‑on experience with CDISC standards and regulatory data frameworks Programming proficiency in SAS (required); exposure to R preferred Familiarity with real‑world evidence (RWE) and observational research methods is a plus Working knowledge of global regulatory expectations and submission processes Leadership & Communication Ability to translate complex statistical concepts into clear, actionable insights for non‑technical stakeholders Strong collaboration skills with cross‑functional teams and external partners Proven ability to manage multiple priorities in a dynamic development environment Why This Role Opportunity to influence end‑to‑end clinical development strategy High visibility across cross‑functional leadership and regulatory interactions Exposure to both clinical trials and real‑world evidence generation Collaborative and innovation‑driven culture focused on improving patient outcomes Compensation & Benefits Competitive base salary in the range of approximately $120,000 - $165,000 , with bonus and additional incentives Comprehensive benefits package including healthcare, retirement plans, paid time off, and wellness support #J-18808-Ljbffr EPM Scientific