Senior Manager, Biostatistics

Responsibilities

• Serve as lead statistician for clinical studies and support program-level statistical strategy
• Lead statistical activities and collaborate with statistical programmers and CRO partners
• Author and review statistical sections of study protocols, analysis plans, and clinical study reports
• Maintain knowledge of statistical methodologies and regulatory guidance in oncology drug development
• Contribute statistical expertise to due diligence and cross-functional evaluations
• Drive process improvements and standards development within the Biostatistics function

Requirements

• PhD in Statistics, Biostatistics, or related field with 3–5 years of industry experience, or MS with 6–8 years of experience
• Strong experience in oncology clinical development (early- and late-phase trials)
• Knowledge of survival analysis, patient-reported outcomes, and health economics
• Proficiency in SAS
• Strong verbal, written, and presentation skills

Preferred Qualifications

• Working knowledge of FDA, EMA, and ICH statistical guidance
• Experience supporting regulatory submissions such as NDA, BLA, or MAA
• Familiarity with R

About the Company

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells.