Senior Manager/Associate Director, Statistical Programming

Role: Senior Manager/Associate Director of Statistical Programming leading clinical trial data analysis within Rapport's Bipolar Mania program, supporting Phase I-IV studies from protocol design to regulatory submissions. Responsibilities: develop, validate, and document SAS programs for SDTM, ADaM, and TLF outputs; oversee CRO/vendor deliverables; ensure compliance with industry standards (CDISC, ICH, FDA/EMA); contribute to programming standards and automation; collaborate with Biostatistics leadership and cross-functional teams to improve data quality and efficiency. Requirements: Master’s/Bachelor’s in Computer Science, Statistics, or related field; 8-10 years in statistical programming in biotech/pharma/CRO, expert in SAS (Base, Macro, STAT, GRAPH), with strong CDISC experience; knowledge of GCP, ICH, FDA/EMA guidelines; experience managing internal and external teams; support for regulatory submissions preferred; familiarity with R/Python a plus; experience in neurology or CNS therapeutics desirable. High-Value: bipolar disorder, epilepsy, PGTCS, bipolar disorder indications; biologics or small molecules, clinical stage (Phases I-IV); GxP, biometrics, regulatory submission support. Collaboration: report to Biometrics leadership, manage CRO/vendor relationships. Work Setup: hybrid in Boston MA (onsite Mon-Wed), with competitive compensation ($200K-$220K range), and comprehensive benefits.