Manager, Statistical Programming
Gilead SciencesFull Time
Expert & Leadership (9+ years)
Candidates must possess a Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, or a related field. Strong proficiency in SAS programming is required, with experience in R or Python being a plus. In-depth knowledge of CDISC standards (SDTM and ADaM), FDA/EMA regulatory requirements, and ICH guidelines is essential. Experience with eCTD submission programming and contributing to BLA/NDA/MAA filings is preferred. Strong attention to detail, excellent organizational and communication skills, and a proactive, solution-oriented mindset are necessary. The ability to work effectively in a lean, cross-functional, start-up environment is also required.
The Associate Director, Statistical Programming will lead statistical programming activities across clinical development programs, reporting to the Head of Biostatistics. Key responsibilities include building internal capabilities, ensuring high-quality programming deliverables for regulatory and clinical milestones, and working with internal stakeholders. This role involves overseeing vendors, performing CDISC compliance checks, programming ad hoc datasets and tables, listings, and figures (TFL), and ensuring regulatory acceptance of datasets. The individual will lead the development, validation, and documentation of statistical programming deliverables, collaborate with internal teams and CRO partners to ensure quality and compliance, and serve as the primary programming lead across multiple studies or programs. Responsibilities also include developing and maintaining programming standards, tools, and processes, providing strategic input to study design and data flow, reviewing protocols and SAPs, supporting regulatory document preparation, and partnering with various functional teams to ensure alignment of timelines and deliverables. Additionally, the role involves contributing to vendor selection and performance management for programming activities.
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.