Senior Director, Statistical Programming

Role: Senior leader responsible for strategic and technical oversight of Bicycle's statistical programming functions within clinical development, ensuring high-quality, compliant data analysis for biotech trials. Responsibilities include providing expert leadership on programming standards (SDTM, ADaM), managing external vendors and CROs, defining long-term strategies for process efficiency, and mentoring programming teams. The role entails ensuring documentation readiness for regulatory audits, driving innovation in workflows, and aligning programming activities with overall clinical objectives. Requirements: Extensive experience in statistical programming (SAS expertise), deep understanding of CDISC standards, proven leadership in biotech/pharma, with a focus on clinical data for regulatory submissions. Experience preferably in oncology, managing complex clinical trial portfolios, and vendor governance. Qualifications include a strong background in biotech/pharma with a track record of leading programming strategies, deep regulatory knowledge, and vendor oversight skills. High-Value: Cell/gene or biologics modalities, early to late-phase clinical trials, regulatory compliance (ICH/GCP), expertise in preparing datasets for NDA/BLA submissions, and cross-functional collaboration with biostatistics, clinical operations, and regulatory teams. Work setup: Hybrid in Lexington, MA, with 2-3 days onsite weekly.