Associate Director, Director, Biostatistics

Summary

Join Dianthus Therapeutics, a clinical-stage biotechnology company, as an Associate Director or Director of Biostatistics to lead statistical activities across Phase III clinical programs. Reporting to the Head of Biostatistics, you will provide strategic and technical leadership in the design, analysis, and interpretation of clinical trials. Collaborate with cross-functional teams, including Clinical Development, Clinical Operations, and Regulatory, to deliver high-quality statistical deliverables. This role offers direct visibility across the company and the opportunity to contribute to regulatory submissions and interactions. Dianthus Therapeutics is building a culture focused on patient care and offers remote work options. This is an exciting opportunity to join a growing team with ongoing Phase III development and multiple streams of regulatory agency interactions.

Requirements

• Ph.D. or M.S. in Biostatistics, Statistics, or related field
• Must have experience in the Biotech/Pharma Industry or CRO
• Hands-on experience leading statistical activities for clinical trials across multiple phases
• Expertise in clinical trial methodology, adaptive designs, and regulatory guidance
• Proficiency in SAS, including with data simulation and analysis; familiarity with CDISC standards (SDTM/ADaM)
• Strong communication and interpersonal skills, with the ability to explain statistical concepts to non-statisticians
• Demonstrated ability to work independently and thrive in a fast-paced, start-up environment

Responsibilities

• Serve as the lead biostatistician for one or more clinical programs or trials from Phase I through Phase III
• Provide strategic input into clinical development plans, study designs, and statistical methodologies; present statistical aspects of development planning to internal stakeholders
• Develop or review statistical sections of clinical trial protocols, SAPs (Statistical Analysis Plans), and other key study documents
• Collaborate with internal teams and CROs to oversee statistical programming, analysis, and validation of results
• Interpret and communicate statistical results to clinical and regulatory stakeholders
• Contribute to regulatory submissions including ISS/ISE, briefing books and responses to health authority questions; attend meetings with regulatory agencies
• Ensure statistical deliverables comply with regulatory requirements (e.g., FDA, EMA, ICH)
• Identify opportunities for process improvements and implement innovative statistical solutions
• Represent Biostatistics in cross-functional project teams and contribute to decision-making

Preferred Qualifications

Experience with regulatory submissions and interactions (NDA/BLA/MAA)

Benefits

We are open to you working remotely