Associate Director Biostatistics

Associate Director, Biostatistics (Boston, MA metro area; Hybrid 3 days onsite)

• 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.

• 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, up to date knowledge of statistical applications and the ability to communicate complex concepts clearly to diverse audiences.
• Proficiency in SAS and R, and familiarity with CDISC SDTM and ADaM standards.
• Experience contributing to NDAs, MAAs, or other global regulatory submissions.
• Ability to collaborate effectively with CRO partners and manage outsourced statistical activities.
• Strong interpersonal and communication skills, with the ability to build trust and guide cross‑functional decision‑making.
• Demonstrated accountability, strong analytical thinking, and a data‑driven approach to problem‑solving.
• Ability to work both independently and within a collaborative, matrixed team environment.
• Sense of urgency, initiative, and adaptability in a fast‑moving, small‑company setting.
• Excellent organizational, time management, and project leadership skills.
• High attention to detail and strong problem‑solving capabilities.
• Willingness to learn, grow, and contribute to Company’s mission.

• 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.
• Expertise in statistical methods for clinical trials.
• Proficiency in SAS and R.

• Experience contributing to NDAs, MAAs, or other global regulatory submissions.
• Ability to collaborate effectively with CRO partners.
• Strong interpersonal and communication skills.