Senior Principal Biostatistician - Lead Clinical Trials

Incyte; Wilmington (DE); On-site; USD 120,000 - 170,000; Full time

Job summary

Incyte, a global biopharmaceutical company headquartered in Wilmington, Delaware, seeks a statistical expert to lead data processing and analysis for Phase I–III trials. The role emphasizes independent work, leadership of project teams, and collaboration across cross-functional groups within a regulated environment.

The incumbent will develop analysis datasets, write SAS programs, and contribute to study reports and protocols, ensuring alignment with FDA/EMEA guidelines.

Qualifications

• PhD in Statistics/biostatistics required.
• Hands-on experience with clinical trial data.
• Experience in pharma/biotech environments.
• Strong expertise in multivariate analyses and biomarker analyses is a plus.
• Experience with regulatory discussions and filing strategies.
• Ability to work autonomously and lead projects.
• Knowledge of FDA/EMEA guidelines.
• Excellent communication and team leadership.

Responsibilities

• Process clinical data for statistical analysis of Phase I–III trials.
• Lead project teams and ensure timely delivery of analysis datasets, tables, listings, and figures.
• Develop and enforce SOPs and guidelines for statistical activities.
• Contribute to pre-IND and NDA activities and to Clinical Development Plans.
• Assist in writing relevant sections of clinical study reports.
• Provide statistical input to study protocols and timelines.
• Interact with multidisciplinary teams to align project milestones.

Skills

Statistical analysis

Biostatistics

SAS

Education

PhD in Statistics/biostatistics

Advanced degree in statistics

Tools

SAS

Job description

Incyte, a global biopharmaceutical company headquartered in Wilmington, Delaware, seeks a statistical expert to lead data processing and analysis for Phase I–III trials. The role emphasizes independent work, leadership of project teams, and collaboration across cross-functional groups within a regulated environment.

The incumbent will develop analysis datasets, write SAS programs, and contribute to study reports and protocols, ensuring alignment with FDA/EMEA guidelines.