Senior Principal Biostatistician

Incyte Corporation; Wilmington (DE); On-site; USD 120,000 - 180,000; Full time

Job summary

Incyte Corporation in Wilmington, Delaware seeks a senior statistician to lead statistical activities across Phase I–III trials. You will process clinical data for analyses, write SAPs, and contribute to study reports, ensuring high data quality and regulatory compliance.

The role requires a PhD in statistics/biostatistics with pharma experience, SAS proficiency, and collaboration with cross-functional teams and health authorities. On-site presence is expected in a dynamic biopharma environment.

Qualifications

• PhD in Statistics/biostatistics required with pharma/biotech trial experience.
• Strong background in statistical methodology.
• Experience with FDA/EMEA guidelines and drug development.

Responsibilities

• Process clinical data for statistical analysis in trials Phase I-III.
• Lead project teams and coordinate timelines.
• Develop and enforce SOPs and guidelines.
• Write statistical analysis plans and contribute to study reports.
• Interpret results and review statistical summaries.
• Collaborate with multidisciplinary teams and health authorities.

Skills

SAS proficiency

Statistical methodology

Autonomy in project work

Team collaboration

Education

PhD in Statistics/Biostatistics

Tools

SAS

Job description

Overview

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

The job is based in Wilmington Delaware, US. (Minimum 3 days per week in the office. Local candidates or those willing to relocate only).

Job Summary (Primary function)

This role is responsible for processing clinical data required for statistical analysis of Phase I — III clinical trials and leading project teams.

Essential Functions of the Job (Key responsibilities)

• Other responsibilities as required.
• Participate in the development and enforcement of SOPs and guidelines.
• Participate in pre-IND and NDA activities.
• Participate and contribute to authoring of Clinical Development Plan.
• Assist in writing relevant sections of the clinical study report.
• Interpret study results and provide review of statistical summary reports of study results for accuracy.
• Provide guidance and support to team members in creating analysis dataset specifications and programming of tables, listings, and figures.
• Write statistical analysis plans.
• Provide statistical input to study protocols.
• Interact with members of the multidisciplinary project teams to establish project timelines.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• PhD in Statistics/biostatistics, Working experience in pharma/biotech, hands on working experience in clinical trials
• Strong technical background for statistical methodology work
• Proficiency in using SAS to perform efficacy analyses and validate important data derivations when necessary
• Familiarity with multivariate analyses and biomarker analyses is beneficial.
• Experience in collaborating with health authorities, including discussions and negotiations in filing strategies, is highly valued. Able to effectively communicate their ideas and to manage team members in a constructive manner.
• Demonstrate ability to work autonomously in project management and decision making.
• Several years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.
• Advanced degree in statistics or equivalent experience preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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