Our client, a clinical-stage biopharmaceutical company focused on Rare Diseases, is seeking a Senior Manager or Associate Director of Biostatistics to join their growing team. This is a unique opportunity to serve as the second Statistician in the organization and take on a strategic leadership role in driving statistical design and analysis for clinical trials across all phases of development. *This role can come in at Director level for an exceptional candidate, depending on experience.

Key Responsibilities:

• Serve as the lead statistician on clinical development studies, from protocol design through regulatory submission
• Develop statistical analysis plans, author mock analysis packages (tables, figures, listings), and contribute to clinical study reports
• Partner closely with data management to align CRFs with protocols and SAPs; conduct user acceptance testing (UAT) for clinical trial systems
• Oversee and collaborate with internal or CRO programmers to ensure quality and timely delivery of TFLs
• Contribute to regulatory submissions including eCTDs, briefing documents, and responses to health authority queries
• Stay current with FDA, ICH, and other regulatory statistical guidelines

Qualifications:

• Ph.D. in Biostatistics, Statistics, Mathematics, or a related field
• Minimum of 4 years’ experience in clinical trials within the pharmaceutical or biotech industry (for the Senior Manager level); MS 7+ years
• Strong knowledge of statistical experimental design and regulatory requirements for clinical studies
• Proficiency in statistical programming using SAS and/or R
• Experience with eCTD submissions and direct interactions with regulatory authorities
• Strong communication and interpersonal skills; ability to thrive in a dynamic and evolving environment

This is a highly visible and impactful role with room for growth as the company advances its pipeline. If you're ready to bring your statistical leadership to a company making a difference in the Rare Disease space, we encourage you to apply.