Associate Director, Statistical Programming

Associate Director, Statistical Programming Associate Director, Statistical Programming Waltham, Massachusetts, United States Position Overview Sironax is seeking a highly motivated and experienced Associate Director, Statistical Programming to play a critical leadership role within our global clinical development organization. This position combines strategic oversight with hands-on programming expertise, offering a unique opportunity to influence clinical development, regulatory submissions, and corporate milestones. The ideal candidate is adaptable, collaborative, and thrives in a fast-paced biotech environment. You will oversee CRO programming deliverables while also supporting high-priority internal analyses, executive presentations, and regulatory reporting activities across multiple therapeutic areas, including rare diseases. Key Responsibilities Lead oversight and management of CROs and external vendors to ensure timely, high-quality delivery of SDTM, ADaM, and TFL outputs. Provide hands-on statistical programming support for internal analyses, executive presentations, investor materials, and regulatory submissions. Collaborate closely with cross-functional teams including Biostatistics, Clinical Operations, Data Management, Regulatory Affairs, and Investor Relations. Maintain alignment across global teams, including effective collaboration with US- and China-based stakeholders across multiple time zones. Ensure compliance with CDISC standards, FDA/EMA regulatory requirements, and industry best practices. Support programming activities across a diverse clinical pipeline, including complex and data-limited rare disease programs. Contribute to process improvement initiatives, programming standards, and operational efficiencies within the statistical programming function. Qualifications Bachelor’s or Master’s degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related quantitative discipline. Minimum of 8 years of statistical programming experience within the biotechnology or pharmaceutical industry. At least 2 years of leadership, vendor oversight, or project management experience. Advanced proficiency in SAS programming; experience with R programming is highly desirable. Strong knowledge of CDISC standards (SDTM and ADaM) and regulatory submission requirements. Experience supporting regulatory submissions and corporate milestones such as investor presentations or fundraising activities is preferred. Excellent communication and collaboration skills with the ability to work effectively in a global environment. #J-18808-Ljbffr