Senior Principal Biostatistician (Biotech)

Location: Wilmington, Delaware, United States; minimum three days per week in the office. Local candidates or candidates willing to relocate only.

Company

hirify.global is a global biopharmaceutical company developing proprietary therapeutics in Hematology, Oncology, Inflammation, and Autoimmunity, with operations in North America, Europe, and Asia.

What you will do

• Process clinical data required for statistical analysis of Phase I–III clinical trials.
• Write statistical analysis plans and provide statistical input to study protocols.
• Interpret study results and review statistical summary reports for accuracy.
• Guide the creation of analysis dataset specifications and the programming of tables, listings, and figures.
• Contribute to clinical development plans, clinical study reports, pre-IND activities, and NDA activities.
• Lead and coordinate multidisciplinary project teams, timelines, SOPs, and statistical guidelines.

Requirements

• PhD in Statistics or Biostatistics, or equivalent advanced education and experience.
• Several years of experience in the pharmaceutical or biotechnology industry and hands-on clinical trial experience.
• Strong technical background in statistical methodology and broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.
• Proficiency in SAS for efficacy analyses and validation of important data derivations.
• Ability to work autonomously in project management and decision-making, communicate effectively, and manage team members constructively.

Nice to have

• Familiarity with multivariate analyses and biomarker analyses.
• Experience collaborating with health authorities on filing strategies.

Culture & Benefits

• Hybrid work arrangement with regular office attendance.
• Employment with an equal-opportunity biopharmaceutical organization.
• Work connected to the development and commercialization of first-in-class medicines for patients with unmet medical needs.