POSITION SUMMARY:

The Senior Manager, Clinical & Statistical Programming will be responsible for planning, executing and quality checking of data programming and statistical analysis deliverables to support clinical trial conduction and prepare submission readiness package. This role provides technical and operational leadership to ensure compliant, high-quality analysis datasets, tables, listings, and figures (TLFs) in accordance with CDISC standards and FDA guidance. This role will operate as an individual contributor; contribute significantly in building statistical programming infrastructure of the Biometric department; and may have the opportunity to lead contractors/CROs/Collaborators in preparing highly efficient, meta data driven, regulatory standards compliant clinical and statistical programming for pipeline trials.

This role will partner closely with Biostatistics, Clinical Data Management, Clinical Operations, Medical Team, and Regulatory Affairs to support submission readiness and successful regulatory interactions.

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

CORE ACCOUNTABILITIES:
Specific responsibilities include:  

• Perform clinical and statistical programming activities for clinical trials and ensure the timely delivery of high-quality outputs throughout the full study life cycle.
• Review clinical trial protocols, SAP, CRF designs, and EDC deployments, and provide input for EDC edit checks to enhance clinical trial data quality.
• Guide and review outputs from CROs, which may encompass submission datasets, programs, and outputs to ensure the submission package (SDTM and ADaM specifications, SDTM and ADaM programs and datasets, Tables, Listings, and Figures (TLFs) outputs, define.xml, and reviewer guides, etc.)  adheres to regulatory requirements and is compliant with CDISC standards.
• Execute and support clinical and statistical programming activities for regulatory submissions including INDs, NDAs, and/or BLAs.
• Review data management plans, data transfer plans, and test EDC deployment to ensure readiness for downstream programming.
• Provide hands-on SAS programming support for key safety and efficacy analyses of clinical trials, as well as ad hoc exploratory and publication analyses as required.
• Provide technical oversight to statistical and data programmers and contractors as necessary.
• Collaborate closely with biostatisticians, study physicians, data management, clinical operations, and safety review teams to review data or programming issues and improve the overall quality of clinical trial data.
• Support internal and external audits, inspections, and regulatory inquiries related to statistical programming deliverables.
• Assist the department head in building the infrastructure of the biometrics department, which may include creating macros and programs, TLF shells, departmental SOPs, and best practices for clinical and statistical programming and data traceability.

The successful candidate will have:

• BS in biostatistics, statistics, computer science, or a closely related field, coupled with extensive quantitative analysis methodologies and clinical programming proficiency with a minimum of 8+ years of experience in pharmaceutical companies or CROs is required.
• Demonstrated leadership experience in managing projects and guiding cross functional teams. 
• A solid comprehension of statistical programming principles, advanced SAS programming expertise, extensive experience in the preparation of regulatory submission packages, and substantial knowledge of CDISC standards.
• Exceptional attention to detail and a strong risk-mitigation mindset, a self-driven learner to continuous learning and updating programming skills and therapeutic area (TA) knowledge.
• Excellent verbal, written, and interpersonal communication skills are mandatory for clear and efficient communication and collaboration with cross-functional teams, which may include clinical operations, data management, study physicians, statisticians, and medical writers.
• A sound working knowledge of ICH, FDA, and GCP regulations and guidelines.

Preferred Qualifications:  

• Master's degree preferred
• 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 preferre
• 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: $170,000 - $210,000