Associate Director, Statistical Programming

Waltham, Massachusetts, United States

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.

• 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.

• 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.