Manager Biostatistics

Job Description

Manager, Biostatistics

Location: Northern New Jersey | Hybrid

Our client, a growing biotechnology company focused on non-opioid pain management and regenerative health solutions, is seeking a Manager, Biostatistics to support clinical development and post-marketing activities.

In this role you will be responsible for conducting and overseeing biostatistical activities across all phases of clinical development and post-marketing efforts. You will provide statistical leadership for clinical development programs, contribute to study design and protocol development, develop and review statistical analysis plans, and oversee statistical deliverables generated both internally and by external CRO partners. This is an opportunity to join a growing organization focused on advancing innovative approaches to pain management and regenerative health and to make meaningful contributions across clinical development while partnering with a broad range of scientific, clinical, and regulatory stakeholders.

What You'll Do:

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• Provide statistical leadership for one or more clinical development programs, ensuring consistency, scientific rigor, and quality across statistical deliverables.
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• Manage statistical activities for clinical studies from program development through Clinical Study Report (CSR) development and publication.
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• Serve as the primary statistical point of contact for assigned programs and studies.
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• Contribute to clinical trial protocol development and study design.
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• Perform sample size and power calculations.
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• Develop, review, and contribute to Statistical Analysis Plans (SAPs).
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• Contribute to the design and analysis of clinical trial and real-world data to support evidence generation from randomized controlled trials and observational studies.
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• Collaborate effectively with clinical development, medical affairs, clinical operations, data management, regulatory affairs, and other cross-functional stakeholders.
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• Review and approve statistical deliverables developed internally and by CRO partners.
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• Ensure statistical deliverables meet regulatory standards, company expectations, and applicable quality requirements.
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• Manage biostatistics CRO partners, ensuring adherence to timelines, SOPs, quality standards, and project expectations.
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• Partner with clinical and regulatory teams to identify statistical risks and develop appropriate mitigation strategies.
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• Support interactions with regulatory authorities on statistical topics, including regulatory meetings, responses to information requests, briefing materials, and other communications.
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• Contribute to continuous improvement of biostatistics processes, standards, and quality controls.
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Qualifications

Education & Experience

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• Master’s degree in Statistics, Biostatistics
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• Minimum of 2 years of experience in the biotechnology, pharmaceutical, or related industry .
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• Experience with the statistical design, analysis, and reporting of randomized controlled clinical trials.
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• Hands-on experience supporting clinical development programs is strongly preferred.
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Knowledge, Skills & Abilities

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• Strong understanding of clinical trial design principles, including adaptive designs.
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• Ability to communicate complex statistical concepts and analyses clearly to non-statistical audiences.
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• Ability to balance scientific rigor with operational and business considerations in a fast-paced development environment.
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• Extensive hands-on experience with CDISC methodologies and industry data standards .
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• Strong organizational and project management skills, with the ability to manage multiple priorities and timelines while maintaining high-quality deliverables.
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• Working knowledge of regulatory guidelines and expectations related to pharmaceutical development.
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• Experience supporting interactions with regulatory authorities is a plus.
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• SAS programming experience is required; R experience is a plus.
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• Familiarity with real-world evidence and observational research methodologies, including causal inference, is a plus.
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• Experience supporting clinical development programs in acute or chronic pain indications is a plus.
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• Understanding of SOPs, processes, and quality-control practices within pharmaceutical biostatistics.
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