Senior Biostatistics Lead - Clinical Trials & Submissions

Clinical Dynamix, Inc.; Burlington (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Clinical Dynamix, Inc. seeks an Associate Director, Biostatistics to lead statistical strategies for oncology programs. You will design trials, develop SAPs, and partner with clinical, data management, and regulatory teams to ensure robust analyses and regulatory readiness.

You will mentor statisticians, oversee SDTM/ADaM outputs, and contribute to NDA/MAA submissions in a fast-paced, collaborative environment in Burlington, MA.

Qualifications

• PhD in Biostatistics or related field with 5+ years of industry experience, or MS with 7+ years.
• Experience in oncology drug development preferred.
• Strong knowledge of FDA, EMA, and ICH guidelines, and a solid understanding of the end-to-end drug development process.
• Expertise in statistical methods for clinical trials and ability to communicate complex concepts clearly.

Responsibilities

• Serve as the lead statistician for clinical trials, contributing to efficient study design and rigorous data analysis.
• Provide high-quality statistical support across clinical programs, ensuring scientific robustness and alignment with development goals.
• Design and refine clinical trial methodologies; author study synopses and protocols.
• Collaborate with data management on CRF design and database quality to ensure reliable datasets.
• Develop statistical analysis plans and ensure clear, transparent documentation.
• Guide and mentor statistical programmers in creating SDTM/ADaM specifications, datasets, and statistical outputs.
• Review and approve statistical deliverables to ensure consistency, accuracy, and regulatory readiness.
• Interpret study results and contribute to clinical reports, presentations, publications, and regulatory documentation.
• Author statistical content for regulatory submissions and support interactions with global health authorities.
• Monitor timelines, deliverables, and support resource planning to keep programs on track.
• Participate in vendor selection and provide oversight to ensure high-quality, timely statistical outputs.
• Contribute to the development and evolution of Biostatistics processes, standards, and best practices at Company.
• Communicate proactively, collaborate effectively, and maintain a solutions-oriented approach in a dynamic, fast-paced environment.
• Demonstrate ownership, accountability, and a commitment to delivering high-quality work.
• Provide constructive feedback to support team development and shared success.

Skills

Oncology drug development experience

Regulatory knowledge (FDA/EMA/ICH)

Communication & leadership

Cross-functional collaboration

Problem solving

Project management

Education

PhD in Biostatistics or related field

MS in Biostatistics (7+ years experience)

Tools

SAS

R

CDISC SDTM/ADaM

Regulatory submissions (NDAs/MAAs)

Job description

Clinical Dynamix, Inc. seeks an Associate Director, Biostatistics to lead statistical strategies for oncology programs. You will design trials, develop SAPs, and partner with clinical, data management, and regulatory teams to ensure robust analyses and regulatory readiness.

You will mentor statisticians, oversee SDTM/ADaM outputs, and contribute to NDA/MAA submissions in a fast-paced, collaborative environment in Burlington, MA.