Associate Director, Statistical Programming

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs).

Requirements

• Contribute to team building, departmental strategic planning, resource forecasting or support organizational growth and operational excellence.
• Lead the development, validation, and maintenance of Standard Operating Procedures (SOPs), programming guidelines, and technical documentation to ensure consistency and compliance across all programming activities.
• Develop and implement both short-term and long-term strategies for statistical programming that align with the organization’s scientific and operational objectives, including establishing goals, metrics, and progress monitoring.
• Provide expert guidance on statistical programming best practices, programming standards, and automation strategies.
• Ensure timely, high-quality delivery of statistical programming outputs, including SDTM and ADaM datasets, Define.xml, tables, listings, and figures (TLFs) in compliance with CDISC, ICH, FDA, and EMA standards.
• Lead, mentor, and develop a team of programmers and managers, fostering a high-performance, accountability, and collaborative culture.
• Manage programming support for regulatory submissions, clinical study reports, publications, exploratory analyses, and ad hoc requests.
• Oversee the full lifecycle of programming activities across clinical studies both internally and externally - from planning and development to execution, validation, and delivery.

Benefits

• 100% paid employee premiums for medical/dental/vision
• STD and LTD coverage
• 401(k) plan with a 50% company match of up to 3%
• 15 PTO days per year
• Sick leave
• 11 paid holidays
• MORE