Data Science Lead

This is an exciting opportunity to lead, develop, and oversee statistical strategies and deliverables in support of clinical trials.

• Serve as biostatistics leader for assigned studies and projects, providing statistical expertise and guidance to ensure successful trial outcomes.
• Lead or contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation, ensuring that all aspects of the study are thoroughly considered.
• Author and review Statistical Analysis Plans (SAPs), including mock tables, figures, and listings (TFLs), to ensure accuracy and compliance with regulatory requirements.
• Oversee and ensure the execution of statistical analyses per SAP in collaboration with programming and CRO partners, ensuring timely completion of high-quality results.
• Provide statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverables, to ensure seamless integration with project timelines.
• Regularly communicate project status to management and escalate issues or risks in a timely manner, maintaining open and transparent communication throughout the project lifecycle.
• Provide statistical input and review for clinical study reports, regulatory documents, and publications, ensuring that all outputs are accurate, complete, and compliant with regulatory standards.
• Perform quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards, identifying areas for improvement and implementing corrective actions as needed.
• Lead or support regulatory interactions on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerations, ensuring that all stakeholders are informed and aligned with project goals.
• Deliver statistical presentations to internal and external stakeholders, or regulatory authorities as needed, effectively communicating complex statistical concepts and results.
• Contribute to the development, review, and maintenance of statistical standard operating procedures (SOPs), Working Instructions (WIs) and internal guidelines, ensuring that all processes are up-to-date and compliant with regulatory requirements.
• Stay current with emerging statistical methodologies and evolving clinical trial practices, applying new knowledge and techniques to drive innovation and excellence in statistical services.

• A Master's degree or PhD in Biostatistics, Statistics, or a related quantitative field is required.
• A minimum of 8 years of experience in clinical trial biostatistics is required for MS-level candidates; a minimum of 6 years is required for PhD-level candidates.
• Proficiency in statistical programming in SAS is required; knowledge of R and other programming languages is preferred.
• Solid knowledge of statistical methodologies and clinical trial designs is essential.
• Strong understanding of CDISC standards (e.g., SDTM, ADaM) and their application is necessary.
• Experience with regulatory support and interaction is required.
• Experience providing statistical oversight of vendors and managing CRO collaborations is highly valued.
• Proven ability to manage multiple studies and timelines concurrently is essential.
• Excellent verbal and written communication skills, with the ability to explain statistical concepts to non-statisticians, are critical.
• Ability to work as a team and have skills to convince your position within cross-functional teams is required.
• Demonstrated ability to communicate statistical concepts and results clearly and effectively is essential.
• Interest in and ability to learn clinical drug development processes is desirable.
• Able to work independently with minimum supervision is highly valued.