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Associate Director of Clinical and Statistical Programming

Umoja BiopharmaSeattle, Washington, United States
Hybrid Full-time $185.1K/yr - $228.7K/yr

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Experience Level

Senior Level Manager

Qualifications

CORE ACCOUNTABILITIESResponsibilities include:Oversee statistical programming activities for clinical trials, ensuring timely delivery of high-quality outputs throughout the study life cycle. Review clinical trial protocols, Statistical Analysis Plans (SAP), Case Report Form (CRF) designs, and Electronic Data Capture (EDC) deployments, providing insights for EDC edit checks to enhance data quality.

About the job

About Umoja Biopharma

Umoja Biopharma is advancing biopharmaceutical research with a focus on integrated immunotherapy for cancer. With teams in Seattle, WA, and Louisville, CO, the company is dedicated to developing off-the-shelf therapies that target a broad range of tumors. Umoja values inventive thinking, technical expertise, and a commitment to improving patient outcomes. The team works from modern facilities in downtown Seattle and Louisville, and welcomes individuals who share a drive for scientific progress in drug development.

Role Overview: Associate Director of Clinical and Statistical Programming

The Associate Director of Statistical Programming leads the planning, execution, and quality oversight of data programming and statistical analysis for clinical trials. This role ensures that all deliverables meet CDISC standards and FDA guidelines, supporting both trial execution and regulatory submission readiness. As an individual contributor, this person will strengthen Umoja’s statistical programming framework and, over time, build and lead a team that may include contractors, vendors, CROs, and full-time employees.

Key Responsibilities

  • Strategically plan and execute statistical programming activities for clinical trials.
  • Oversee the development and quality of analysis datasets, tables, listings, and figures (TLFs).
  • Ensure compliance with CDISC standards and FDA requirements.
  • Collaborate closely with Biostatistics, Clinical Data Management, Clinical Operations, and Regulatory Affairs to support submission readiness and regulatory communications.
  • Enhance and maintain the statistical programming framework within the Biometric department.
  • Build and lead a high-performing programming team, including oversight of contractors, vendors, CROs, and internal staff.

Location and Work Arrangement

This position is based in Seattle, WA, with an on-site requirement of at least two days per week. For highly qualified candidates, remote work within the United States may be considered.

About Umoja Biopharma

Umoja Biopharma is an innovative biotech firm headquartered in Seattle, Washington, dedicated to transforming cancer treatment through advanced immunotherapy solutions. Our collaborative environment fosters creativity and scientific advancement, aiming to deliver effective therapies that make a difference in patients' lives.

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