Senior Manager, Clinical Statistical Programmer

Compass Therapeutics, Inc. was founded in 2014 and is headquartered in Boston, MA. We are an oncology-focused biopharmaceutical company discovering and developing proprietary antibody-based therapeutics to treat multiple diseases. Our robust pipeline currently includes four clinical assets spanning all phases of development, with novel mechanisms of action, and first-in-class or best-in-class potential across multiple tumor types. Our lead clinical-stage asset, tovecimig, has completed a randomized late-stage biliary tract cancer study and we are preparing for a BLA submission. We are now at an exciting inflection point as we scale our organization to support our first product launch. This is a unique and pivotal moment to join us and help make a meaningful impact on patients’ lives. For more information, visit www.compasstherapeutics.com.

Our Clinical team is seeking a hands‑on strategic Senior Manager, Clinical Statistical Programmer, reporting to our Director of Biostatistics. The ideal candidate will have a proven track record of successfully leading clinical safety analysis and programming across multiple programs, in a fast-paced environment. This role combines deep technical expertise in SAS and R with ownership of ongoing safety maintenance and leadership in modern data visualization platforms. The individual will support active trials, long‑term safety monitoring, and the integration of complex data streams, including translational and real-world data (RWD).

This position works onsite 4 days/week in the Brighton, MA office.

 Responsibilities

• Lead Statistical Programming processes, support Clinical strategies, and manage the execution of programming activities across all of our clinical-stage antibody assets and drug candidates in support of commercialization.
• Ensure that Compass Clinical department goals are on track to reach milestones within established timelines, while adhering to quality standards and applicable regulations.
• Provide continuous programming support for active studies, ensuring safety outputs (AEs, SAEs, Labs, Vitals) remain current, validated, and inspection readiness.
• Lead the production of recurring safety outputs and data packages for Data Safety Monitoring Boards and internal safety review committees.
• Oversee medical coding outputs (MedDRA, WHO Drug) and perform clinical-to-safety database SAE reconciliation to ensure data integrity.
• Lead the development of interactive dashboards and exploratory tools using platforms such as Spotfire, R Shiny, or R-based frameworks.
• Create and maintain customized patient profiles to facilitate efficient medical monitor and safety physician reviews.
• Partner with Biostatistics and Clinical Safety teams to translate clinical questions into actionable visual analytics and early trend identification.
• Build and maintain reusable SAS/R macros and standard templates to improve programming efficiency and consistency across the portfolio.
• Develop and execute periodic data quality checks to identify anomalies, trends, or emerging issues early in the study lifecycle.
• Design and maintain complex derived variables and analysis-ready datasets to support evolving reporting requirements.
• Ensure all programming documentation and datasets meet high standards for regulatory submissions and audit readiness.
• Support the roadmap for future real-world data (RWD) and safety data streams.

Qualifications

• Bachelor’s degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related field, and advanced degree is preferred.
• 8+ years of clinical statistical programming experience within the Pharmaceutical, Biotech, or CRO industry.
• Advanced proficiency in SAS (SDTM/ADaM) and R/Python for clinical trial analysis and data visualization.
• In-depth knowledge and proven expertise of clinical safety data structures, medical coding standards, and SAE workflows.
• Demonstrated experience leading implementation and maintaining data visualization platforms (e.g., Spotfire, R Shiny) in a clinical environment.
• Preferred experience handling translational data (e.g., biomarkers, genomics, or PK/PD integration) and its associated complexities.
• Prior experience acting as a programming lead or senior technical contributor with oversight of FTE or vendor-provided deliverables is ideal.
• Exposure to post-marketing safety data or the analysis of real-world evidence (RWE) is preferred.
• Experience identifying critical risks, ability to provide appropriate solutions and mitigate risks; strong work principles and ethical standards are required.
• Strong attention to detail with the ability to balance multiple project objectives in a fast-paced, collaborative work environment.
• Excellent written and verbal communication skills, with the ability to clearly articulate complex data to diverse audiences.