Manager, Statistical Programming

Role: Manager of Statistical Programming responsible for collaboration with clinical teams and vendors to produce high-quality analysis datasets and statistical outputs supporting regulatory and scientific submissions. Responsibilities include generating study report tables, figures, listings; ensuring documentation compliance with departmental procedures; supporting strategic initiatives; and interacting with cross-functional teams to meet project timelines. Qualifications: BS in Biostatistics, Computer Science, or related field with 7+ years in pharma/biotech, or MS with 3+ years, or PhD with 2+ years; extensive experience with statistical programming (SAS, CDISC standards) in regulated environments; strong knowledge of clinical trial design, regulatory reporting (FDA, EMA, PMDA), and regulatory submission processes, especially in oncology, hematology, virology, or inflammation. Skills: excellent communication, problem-solving, and analytical capabilities; proven ability to manage complex, time-sensitive projects and implement strategic initiatives. HighValue: experience with pivotal studies, regulatory submissions (NDA, BLA, MAA), and integrated analysis activities; knowledge of GxP, ICH standards, and electronic data submissions. WorkSetup: not specified.