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
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