Principal Statistical Analyst
About this role
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
Company at a glance
Harvest Integrated Research Organization (HiRO) is a globally oriented, innovative clinical research organization (CRO). With global operations and integrated capabilities, HiRO provides a full range of cross-border solutions and services to its clients, including early pre-clinical strategic planning, clinical trial design, regulatory affairs, pharmacovigilance, statistics, data management, end-to-end project management, and clinical and medical monitoring services.
As an emerging global CRO, HiRO strives to become a market-leading, integrated global clinical research organization that works collaboratively with biotech and pharmaceutical companies to bring new products from the laboratory to the market, providing more effective solutions for patients worldwide.
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