Senior Clinical & Statistical Programmer

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical & Statistical Programmer based in the United States.

The Senior Clinical & Statistical Programmer will play a key role in advancing clinical development programs by delivering accurate, high-quality statistical programming outputs throughout the clinical trial lifecycle. This hands-on position combines advanced SAS expertise with oversight of external programming partners and a strong focus on data integrity and regulatory compliance. You will develop and validate clinical datasets, tables, listings, and figures while supporting clinical study execution and regulatory submissions. Working closely with cross-functional teams, you will help ensure that programming deliverables meet CDISC standards and applicable regulatory requirements. The role offers the opportunity to contribute to evolving programming standards, improve processes, and support innovative therapies in a collaborative biotechnology environment. The position is open to remote candidates across the United States, with a preference for candidates able to work from the Seattle office at least two days per week.

• 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.

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

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