Senior Quantitative Analyst

The Senior Biostatistician will oversee the development, implementation, and execution of statistical strategies in support of clinical trials.

This role is responsible for contributing to the planning, execution, and interpretation of statistical analyses across development programs, ensuring high-quality, timely deliverables that meet regulatory and scientific standards.

Key responsibilities include:

• Leading or contributing to study design discussions, including protocol development, endpoint definition, and sample size estimation.">
• Authoring and reviewing Statistical Analysis Plans (SAPs), including mock tables, figures, and listings (TFLs).">
• Overseeing the execution of statistical analyses per SAP in collaboration with programming and CRO partners.">
• Providing statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverables.">
• Regularly communicating project status to management and escalating issues or risks in a timely manner.">
• Providing statistical input and review for clinical study reports, regulatory documents, and publications.">
• Performing quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards.">
• Leading or supporting regulatory interactions on statistical issues and providing applicable statistical strategies to handle clinical and regulatory considerations.">
• Delivering statistical presentations to internal and external stakeholders or regulatory authorities as needed.">
• Contributing to the development, review, and maintenance of statistical standard operating procedures (SOPs), Working Instructions (WIs), and internal guidelines.">

Required Skills and Qualifications

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

Benefits

The ideal candidate will possess a strong foundation in statistical methodologies, excellent communication skills, and the ability to work collaboratively in a fast-paced environment.

They will be highly motivated, self-directed, and able to adapt to changing priorities while maintaining attention to detail and quality.

As a key member of our team, the successful candidate will have the opportunity to contribute to the development of statistical strategies, collaborate with cross-functional teams, and drive innovation in clinical trial biostatistics.

Join us in shaping the future of clinical trial biostatistics and advancing our mission to improve human health through innovative research and development.