Associate Director / Director, Biostatistics

About Us

About the Role

As the Associate Director or Director, Biostatistics you will lead critical statistical activities across our phase III clinical program.

Reporting to the Head of Biostatistics, you will provide strategic and technical leadership in the design, analysis, and interpretation of clinical trials in a dynamic, fast-paced organization. You will collaborate cross-functionally with Clinical Development, Clinical Operations, Regulatory, Data Management, Medical Writing, and external vendors to ensure the delivery of high-quality and compliant statistical deliverables.

This is an exciting opportunity to join a growing team with ongoing phase III development and multiple streams of regulatory agency interactions. This role has direct visibility across Dianthus Therapeutics, including to senior leadership.  We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key 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 booksand 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.

Experience

• 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).
• Experience with regulatory submissions and interactions (NDA/BLA/MAA) strongly preferred.
• 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.