Associate Director, Biostatistics Job Description: Position Summary The Associate Director, Biostatistics is responsible for partnering with clinical, regulatory, data management and statistical programming teams to deliver robust statistical methodologies that advance clinical program objectives and ensure compliance with industry standards. This individual will contribute to the success of the team and organization by delivering on role- specific responsibilities while upholding our core working behaviors of Trust and Respect, Communication and Feedback, Accountability and Reliability, Objectivity, and Team Balance and Enablement. Key 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 and 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, 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.
Not specified in the original listing.
Not specified in the original listing.
Clinical Dynamix, Inc. focuses on providing expertise in regulatory affairs for the medical product industry. The company aims to ensure compliance with all applicable regulations to facilitate the successful development and commercialization of medi... Read More