Senior Manager Biostatistics

Senior Manager, Biostatistics

Location: Hybrid (NJ 3x a week)
Industry: Biopharmaceutical / Clinical Development

Overview

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.

This is a high-impact opportunity for a biostatistics leader who enjoys working in a collaborative, fast-paced environment and influencing both strategic and operational aspects of clinical development.

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