Senior Manager, Clinical & Statistical Programming (Remote)

Umoja Biopharma; Seattle (WA); Hybrid; USD 170,000 - 210,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401k with 100% match up to 4%

Paid Time Off

Commuter benefits

Cell phone stipend

Job summary

Umoja Biopharma, in Seattle, WA, is seeking a Senior Manager, Clinical & Statistical Programming. You will plan, execute, and quality-check data programming and statistical analyses to support trials and submission readiness per CDISC and FDA guidelines.

The role offers technical leadership, potential CRO collaboration, and cross-functional teamwork with Biostatistics, Clinical Data Management, Operations, Medical, and Regulatory Affairs.

Qualifications

• BS in biostatistics, statistics, computer science or closely related field with 8+ years in pharma/CRO.
• Experience leading cross-functional teams and projects.
• Strong SAS programming and CDISC regulatory submission knowledge.

Responsibilities

• Plan, execute and quality-check data programming deliverables for trials.
• Review SAP, CRFs, and EDC designs to ensure data quality.
• Oversee CROs to meet SDTM/ADaM and submission package standards.
• Support regulatory submissions including INDs/NDAs/BLAs.
• Collaborate with biostatistics, data management, and regulatory teams.
• Develop macros and SOPs to improve programming infrastructure.

Skills

Leadership

SAS programming

CDISC standards

Biostatistics

Regulatory submissions

Communication

Education

Bachelor's degree in biostatistics/statistics/computer science

Master's degree preferred

Tools

R

SAS

Job description

Umoja Biopharma, in Seattle, WA, is seeking a Senior Manager, Clinical & Statistical Programming. You will plan, execute, and quality-check data programming and statistical analyses to support trials and submission readiness per CDISC and FDA guidelines.

The role offers technical leadership, potential CRO collaboration, and cross-functional teamwork with Biostatistics, Clinical Data Management, Operations, Medical, and Regulatory Affairs.