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
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.