Principal Statistical Analyst

Lead / Principal Statistical Programmer (FSP)

Location: Remote

Department: Biometrics / Statistical Programming Role Summary

We are seeking a senior-level Statistical Programmer with demonstrated experience in Phase 2 clinical studies in a sponsor environment. This role emphasizes accountability and ownership of statistical programming deliverables, strong vendor oversight, and close cross-functional collaboration. Position would also be responsible to help develop and maintain dashboards (this can be learned).

The ideal candidate is comfortable operating with a high degree of independence, understands the real-world complexity of clinical data delivery, and takes responsibility for quality, timelines, and outcomes.

Key Responsibilities

• Lead statistical programming activities for Phase 2 clinical studies, serving as the primary programming contact for assigned studies
• Maintain overall accountability for SDTM, ADaM, and TFL deliverables, providing oversight of specifications, programming, validation, and issue resolution performed by external vendors
• Oversee and critically review CRO programming deliverables to ensure quality, consistency, and adherence to timelines and sponsor expectations
• Partner with Biostatistics, Clinical Data Management, and Clinical Operations to support data cleaning, interim analyses, and study decision-making
• Proactively identify risks related to data quality, timelines, and vendor performance, and drive issues to resolution
• Contribute to the development, refinement, and enforcement of programming

standards, processes, and documentation

Required Ǫualifications

• Bachelor’s degree or higher in Statistics, Computer Science, Life Sciences, or a

related field

• 10+ years of statistical programming experience in clinical research
• Demonstrated experience leading Phase 2 clinical studies
• Strong understanding of SDTM, ADaM, and TFL standards and review practices
• Hands-on experience developing dashboards, including data preparation and visualization is a plus
• Proven experience overseeing CROs or external vendors delivering statistical programming outputs
• Solid understanding of clinical trial data flow, data cleaning, and regulatory

deliverables

• Demonstrated ability to take ownership of deliverables, timelines, and issue resolution

Preferred Ǫualifications

• Experience in early- or mid-stage drug development environments
• Prior experience in a small or mid-sized biotech, with comfort operating in a fast-paced, evolving environment
• Strong written and verbal communication skills, with the ability to convey technical information clearly to cross-functional stakeholders

What We’re Looking For

• A leader who demonstrates true accountability, not just coordination
• Someone who understands the operational and analytical complexity of outsourced clinical programming
• A collaborative partner who balances technical depth with strategic oversight
• A self-directed professional who proactively identifies issues and drives solutions