Senior Director, Statistical Methodologist
BiogenFull Time
Senior (5 to 8 years)
Candidates should possess a Master's Degree in Statistics, Biostatistics, Mathematics, Epidemiology, or a related discipline, with a minimum of 10 years of progressive clinical trial programming experience in the biotech/pharma industry. Advanced SAS programming skills and experience with other statistical software like R are required, along with in-depth knowledge of CDISC standards (SDTM, ADaM, controlled terminologies). Experience with Phase 3 and BLA submissions is preferred, as are excellent organizational, communication, and interpersonal skills. Management experience with CROs and other data vendors, strong leadership qualities, a growth mindset, and familiarity with ICH guidelines and regulatory authority guidance are also essential. Experience in a remote virtual environment and a willingness to travel are necessary.
The Associate Director of Statistical Programming will lead statistical programming activities for clinical trial projects, supporting the development of programming processes for studies and submissions. This role involves managing programmers and CROs, overseeing programming activities, and providing timely statistical programming support to cross-functional teams. Key responsibilities include serving as a lead statistical programmer on clinical studies, providing oversight to programming vendors, reviewing and validating vendor-programmed datasets and TFLs, and collaborating with various functions to ensure timely delivery of high-quality data. The position also entails developing and implementing data review/reporting tools, participating in the development of programming processes and standards, reviewing study documents like SAP and DMP, and providing expert feedback. Additionally, the role involves building and mentoring a team of programmers and generating ad hoc analyses.
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.