Senior Director, Statistical Methodologist
BiogenFull Time
Senior (5 to 8 years)
Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases.
As the Associate Director, Statistical Programming, you will lead statistical programming activities across our clinical development programs. Reporting to the Head of Biostatistics, you will be responsible for building internal capabilities and ensuring high-quality programming deliverables for regulatory and clinical milestones. You will work with key internal stakeholders, oversee vendors, perform CDISC compliance checks, program ad hoc datasets and TFL, and ensure regulatory acceptance of datasets. You must have experience within a Biotech, Pharma, or CRO and technical depth to work independently as the lead statistical programmer.
This is an exciting opportunity to join a growing team with ongoing phase III development as the first statistical programming team member, with the opportunity to build a programming infrastructure while directly collaborating with internal stakeholders to ensure the TFL meet company needs. 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.
Develops therapies for autoimmune diseases
Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.