Senior Manager, Clinical & Statistical Programming

Umoja Biopharma

. Plan, execute, and quality check data programming and statistical analysis deliverables for clinical trials .

Posted 10/8/2026full-timeUnited StatesSenior💰 $170,000 - $210,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates advanced SAS programming expertise and extensive experience in regulatory submission preparation, ensuring compliance with CDISC standards and FDA guidelines. Capable of leading cross-functional teams and managing projects throughout the clinical trial life cycle.

Highest-signal resume keywords

Advanced SAS ProgrammingRegulatory Submission PreparationCDISC Standards KnowledgeLeadership in Project ManagementStatistical Programming Principles

ATS Keywords

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Hard Skills

Statistical AnalysisQuantitative Analysis MethodologiesClinical Programming ProficiencyData ProgrammingClinical Trial Protocol ReviewEDC DeploymentSDTM and ADaM SpecificationsTLF CreationMacros DevelopmentRisk Mitigation

Soft Skills

Attention to DetailInterpersonal CommunicationVerbal CommunicationWritten CommunicationSelf-Driven Learning

Tools & Technologies

SASEDC SystemsStatistical Programming InfrastructureData Management ToolsClinical Trial Management Systems

Industry Keywords

BiostatisticsPharmaceutical IndustryCROICH GuidelinesFDA RegulationsGCP Compliance

About the role

Key responsibilities & impact

Plan, execute, and quality check data programming and statistical analysis deliverables for clinical trials
Prepare submission readiness packages
Ensure compliant, high-quality analysis datasets, tables, listings, and figures in accordance with CDISC standards and FDA guidance
Contribute to building statistical programming infrastructure for the Biometrics department
Lead contractors, CROs, and collaborators as needed
Partner with Biostatistics, Clinical Data Management, Clinical Operations, Medical, and Regulatory Affairs teams
Perform clinical and statistical programming throughout the full study life cycle
Review clinical trial protocols, SAP, CRF designs, EDC deployments, and EDC edit checks
Guide and review CRO outputs, including SDTM and ADaM specifications, programs, datasets, TLFs, define.xml, and reviewer guides
Execute and support programming activities for IND, NDA, and BLA regulatory submissions
Review data management and data transfer plans and test EDC deployments
Provide hands-on SAS programming for safety, efficacy, exploratory, and publication analyses
Provide technical oversight to statistical and data programmers and contractors
Collaborate on programming issues and clinical trial data quality
Support audits, inspections, and regulatory inquiries
Assist in creating macros, programs, TLF shells, departmental SOPs, and best practices

Requirements

What you’ll need

BS in biostatistics, statistics, computer science, or a closely related field, coupled with 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
Self-driven learner committed to continuous learning and updating programming skills and therapeutic area knowledge
Excellent verbal, written, and interpersonal communication skills
Sound working knowledge of ICH, FDA, and GCP regulations and guidelines
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
If remote, ability to travel up to 10% as needed

Benefits

Comp & perks

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