[Hiring] Senior Manager, Clinical & Statistical Programming @Umoja Biopharma

Role Description

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.

Qualifications

• BS in biostatistics, statistics, computer science, or a closely related field.
• Extensive quantitative analysis methodologies and clinical programming proficiency.
• Minimum of 8+ years of experience in pharmaceutical companies or CROs.
• Demonstrated leadership experience in managing projects and guiding cross-functional teams.
• Solid comprehension of statistical programming principles.
• Advanced SAS programming expertise.
• Extensive experience in the preparation of regulatory submission packages.
• Substantial knowledge of CDISC standards.
• Exceptional attention to detail and a strong risk-mitigation mindset.
• Excellent verbal, written, and interpersonal communication skills.
• Sound working knowledge of ICH, FDA, and GCP regulations and guidelines.

Requirements

• 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, ensuring compliance with regulatory requirements and 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.
• 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.
• 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.

Benefits

• Competitive Medical, Dental, and Vision plans.
• Access to a 401k plan through Fidelity, with a 100% match up to the first 4% deferral.
• Generous Paid Time Off policy.
• Employee commuter benefits.
• Cell phone stipend.