Director, Data and Science (Analytic Solutions)
Verana HealthFull Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Candidates must possess a Ph.D. in Biostatistics, Statistics, or a related field with at least 7 years of clinical trials experience, or a Master's degree with 10 years of experience. Required qualifications include up-to-date expertise in statistical methodologies for clinical trial design and analysis, the ability to provide statistical leadership to cross-functional teams, knowledge of FDA regulations and ICH guidelines, expertise in CDISC standards (including ADaM requirements), and advanced proficiency in SAS programming. Knowledge of R or similar languages is a plus.
The Director of Biostatistics will lead the statistical strategy for clinical development programs, including study design, protocol input, and statistical analysis planning. Responsibilities include planning and tracking biostatistics timelines and resources, providing statistical input for data management and programming deliverables, and developing statistical programs for ad-hoc requests, manuscripts, and presentations. The role also involves providing statistical review of scientific reports and publications, writing statistical sections for regulatory documents, collaborating with Clinical and Regulatory teams, and participating in the assessment and oversight of CROs, while ensuring compliance with SOPs and industry standards.
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.