Director, Biostatistics (Oncology)

Responsibilities

• Provide statistical leadership and support for assigned oncology clinical trials and programs.
• Oversee and provide statistical guidance on trials within specific programs or platforms.
• Lead the development of statistical analysis plans (SAPs), TLFs, and perform sample size calculations.
• Provide statistical input for clinical development plans, protocols, study reports, and regulatory submission documents.
• Oversee outsourced CRO activities to ensure high-quality deliverables and timely completion.
• Act as the primary Biostatistics representative in cross-functional clinical study teams and for external partners.
• Mentor Associate Directors and junior staff, assuming line management responsibilities as needed.
• Support initiatives to improve statistical standards, processes, and infrastructure.

Requirements

• PhD or Master's degree in (Bio)Statistics, Mathematics, or an equivalent field.
• Minimum of 8 years of experience in the pharmaceutical industry (or 10 years with a Master's degree).
• At least 5 years of leadership experience overseeing internal or outsourced statistics staff.
• Proven experience in the planning, conduct, and analysis of oncology trials from Phase I through Phase IV.
• Strong knowledge of regulatory guidelines including ICH, FDA, and EMA.
• Proficiency in statistical analysis software such as SAS and/or R.
• Experience with sample size calculation software (e.g., EAST or NQuery).

Preferred Qualifications

• Expertise in advanced statistical methods, such as adaptive design or Bayesian approaches.
• Deep understanding of specialized topics including Biomarkers, PK/PD, PRO, AI, RWE, or epidemiology.
• Experience developing and executing outsourcing strategies for statistical activities.

Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(K) plan with company match.
• Paid Time Off including vacation, sick leave, and a year-end U.S. shutdown.
• Parental and childbirth leave assistance.
• Tuition reimbursement and student loan assistance programs.
• Professional development and wellbeing incentive platforms.

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We focus on addressing high medical needs, such as cancer and infectious diseases, through a community of innovators and scientists driven by a shared passion for advancing medicine.