Senior Clinical & Statistical Programmer.

Accountabilities:

• Perform hands-on clinical and statistical programming activities across the clinical trial lifecycle, ensuring accurate, timely, and high-quality deliverables.

• Develop, validate, and quality-check SDTM and ADaM datasets, specifications, tables, listings, and figures (TLFs) in accordance with CDISC standards.

• Provide advanced SAS programming support for safety, efficacy, exploratory, ad hoc, and publication analyses.

• Review clinical trial protocols, statistical analysis plans (SAPs), case report forms (CRFs), and data specifications to ensure programming requirements are clearly addressed.

• Validate programming outputs, identify data or programming issues, and implement appropriate resolutions.

• Review deliverables from CROs, contractors, and external collaborators to ensure quality, accuracy, consistency, and compliance with established standards.

• Support regulatory submission preparation, including SDTM and ADaM datasets, TLFs, define.xml files, reviewer guides, and supporting documentation.

• Contribute to programming activities for INDs, BLAs, and other regulatory submissions and requests.

• Partner with Biostatistics, Clinical Data Management, Clinical Operations, Medical, Safety, and Regulatory Affairs to address clinical data and programming needs.

• Develop and maintain reusable programs, macros, standards, SOPs, and tools to strengthen programming quality and operational efficiency.

• Support internal and external audits, inspections, and regulatory inquiries related to clinical and statistical programming deliverables.

Requirements:

• Bachelor's degree in Biostatistics, Statistics, Computer Science, or a closely related discipline; a master's degree is preferred.

• At least 5 years of relevant clinical and statistical programming experience in the pharmaceutical, biotechnology, or CRO industry.

• Demonstrated hands-on experience developing and validating clinical trial programming deliverables, supporting study execution, preparing regulatory submissions, and maintaining programming standards and processes.

• Advanced SAS programming skills and a strong understanding of statistical programming principles and regulatory submission requirements.

• Thorough knowledge of CDISC standards, including SDTM and ADaM.

• Strong working knowledge of ICH, FDA, and Good Clinical Practice (GCP) regulations and guidelines.

• Exceptional attention to detail, with a strong commitment to quality, risk mitigation, and continuous professional development.

• Excellent written, verbal, and interpersonal communication skills, with the ability to collaborate effectively across clinical, scientific, and technical teams.

• Preferred: Experience supporting NDA or BLA submissions, interacting with regulatory agencies, and leading early- and late-phase clinical trials.

• Preferred: Experience in immunology, hematology, or oncology clinical trials.

• Preferred: Experience using R for clinical analysis.

• Ability to work with detailed technical documentation, datasets, tables, listings, figures, and other on-screen materials for extended periods.

• Remote candidates must be able to travel up to 10% as needed. Candidates based near Seattle are ideally expected to work onsite at least two days per week.

Benefits:

• Annual salary range of $153,000–$189,000.

• Competitive medical, dental, and vision insurance plans.

• 401(k) retirement plan through Fidelity, with a 100% employer match on the first 4% of employee contributions.

• Generous paid time off policy.

• Employee commuter benefits.

• Cell phone stipend.

• Remote work flexibility for eligible candidates based in the United States.