Senior Clinical & Statistical Programmer

POSITION SUMMARY  

The Senior Clinical & Statistical Programmer will perform clinical and statistical programming activities across Umoja's clinical development programs, including the development, validation, and quality control of analysis datasets, tables, listings, and figures (TLFs). As an experienced individual contributor, this role will provide hands-on SAS programming expertise, review work produced by CROs and external partners, troubleshoot complex data and programming issues, and support clinical trial execution and regulatory submission readiness. This position will collaborate closely with Biostatistics, Clinical Data Management, Clinical Operations, Medical, Safety, and Regulatory Affairs to ensure high-quality, timely deliverables that meet CDISC standards, regulatory requirements, and internal quality standards. 

This role will ideally be based out of our Seattle, WA location and work onsite at least 2 days per week. We are open to remote candidates within the U.S. for the right candidate. 

CORE ACCOUNTABILITIES 

Specific responsibilities include:    

• Perform hands-on clinical and statistical programming activities across the clinical trial lifecycle, ensuring timely and high-quality deliverables.
• Develop, validate, and QC SDTM and ADaM datasets, specifications, tables, listings, and figures (TLFs) in accordance with CDISC standards.
• Provide hands-on SAS programming support for safety, efficacy, exploratory, ad hoc, and publication analyses.
• Review clinical trial protocols, statistical analysis plans (SAPs), CRFs, and data specifications to ensure programming requirements are appropriately addressed.
• Perform quality control and validation of programming deliverables and identify and resolve programming or data-related issues.
• Review programming deliverables produced by CROs, contractors, and external collaborators for quality, accuracy, and compliance with established standards.
• Support the preparation of regulatory submission deliverables, including SDTM and ADaM datasets, TLFs, define.xml, reviewer guides, and associated documentation.
• Support programming activities associated with INDs, BLAs, and other regulatory submissions or requests.
• Collaborate closely with Biostatistics, Clinical Data Management, Clinical Operations, Medical, Safety, and Regulatory Affairs to address data and programming needs.
• Contribute to the development and maintenance of reusable programs, macros, programming standards, SOPs, and other tools that improve programming quality and efficiency.
• Support internal and external audits, inspections, and regulatory inquiries related to clinical and statistical programming deliverables. 

The successful candidate will have: 

• BS in Biostatistics, Statistics, Computer Science, or a closely related field; MS preferred.
• Minimum of 5 years of relevant clinical and statistical programming experience within the pharmaceutical, biotechnology, or CRO environment, with experience in hands-on programming, development and validation of clinical trial deliverables, study execution, regulatory submission support, and programming standards and processes.
• Strong knowledge of statistical programming principles, advanced SAS programming expertise, experience preparing regulatory submission packages, and strong knowledge of CDISC standards.
• Exceptional attention to detail and a strong quality and risk-mitigation mindset, with a commitment to continuously developing programming skills and therapeutic area knowledge.
• Excellent verbal, written, and interpersonal communication skills, with the ability to collaborate effectively with cross-functional partners including Clinical Operations, Data Management, study physicians, Biostatistics, and Medical Writing.
• Strong working knowledge of ICH, FDA, and GCP regulations and guidelines. 

Preferred Qualifications:    

• Prior experience with NDA/ BLA submission and interaction with regulatory agencies is highly desirable, as is leading early and late-phase clinical trials.
• Experience in immunology, hematology, or oncology clinical trials is preferred
• Experience with using R in clinical analysis 

Physical Requirements:    

• Ability to sit for prolonged periods of time
• Ability to read, interpret, and review detailed technical documents, datasets, tables, listings, figures, and on‑screen material
• This role will ideally be based out of our Seattle, WA office and will be onsite 2 days/week
• If this role is remote, the ability to travel up to 10% as needed 

Salary Range: $153,000 - $189,000