Senior Principal Biostatistician

Incyte Corporation•Wilmington, DE

11d•Hybrid

About The Position

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

Requirements

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
Several years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.
Demonstrate ability to work autonomously in project management and decision making.

Nice To Haves

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.
Advanced degree in statistics or equivalent experience preferred.

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.