Senior Manager, Clinical & Statistical Programming

Role overview

A senior individual-contributor role at a clinical-stage oncology biotech developing off-the-shelf immunotherapies. The position leads clinical and statistical programming activities across the trial lifecycle and supports regulatory submissions, partnering closely with biostatistics, clinical operations, data management, and regulatory affairs to deliver CDISC-compliant analysis datasets and submission packages.

Responsibilities

- Plan, execute, and quality-check data programming and statistical analysis deliverables across the full study life cycle - Review protocols, statistical analysis plans, CRF designs, and EDC deployments to strengthen trial data quality - Guide and review outputs from CROs to ensure submission packages (SDTM and ADaM specs, datasets, define.xml, reviewer guides, TLFs) meet regulatory and CDISC standards - Provide hands-on SAS programming for safety, efficacy, exploratory, and publication analyses - Support IND, NDA, and BLA submissions through statistical programming contributions - Help build biometrics department infrastructure including macros, TLF shells, SOPs, and best practices - Assist with internal and external audits, inspections, and regulatory inquiries

Requirements

- BS in biostatistics, statistics, computer science, or a closely related field - 8+ years of clinical programming experience within pharmaceutical companies or CROs - Advanced SAS programming expertise and substantial knowledge of CDISC standards - Demonstrated leadership of projects and cross-functional teams - Working knowledge of ICH, FDA, and GCP regulations and guidelines - Strong written and verbal communication skills for cross-functional collaboration

Nice to have

- Master's degree - Prior NDA/BLA submission experience and direct interaction with regulatory agencies - Experience in immunology, hematology, or oncology clinical trials - Experience using R in clinical analysis

Benefits and work setup

- Ideally based in Seattle, WA with on-site presence 2 days per week; remote within the US considered for strong candidates - Up to 10% travel expected for remote candidates - Salary range of $170,000-$210,000 - Medical, dental, and vision plans - 401(k) through Fidelity with 100% match on the first 4% of employee deferrals - Generous paid time off, commuter benefits, and cell phone stipend