Associate Director Biostatistics

Responsibilities

• Represent Statistics in cross-functional clinical study teams and hold accountability for all statistical aspects of clinical development plans.
• Lead the development of statistical analysis plans (SAPs) and TLFs, perform statistical analyses, and validate results.
• Provide statistical input for clinical study protocols, reports, regulatory submission documents, and publications.
• Oversee outsourced CRO activities and deliverables to ensure high quality and timely completion.
• Perform and verify sample size calculations and participate in planning for health authority meetings.
• Provide guidance to Statistical Programmers on SDTM/ADaM and TLF specifications.
• Support the development of departmental strategies and collaborate with Clinical Data Managers to ensure data quality.

Requirements

• PhD or Masters in (Bio)Statistics, Mathematics, or an equivalent field.
• Minimum 5 years of experience in the pharmaceutical industry or CRO (8 years for Masters holders).
• At least 3 years of leadership experience overseeing statistics staff or representing biostatistics in a matrix organization.
• Proven experience in planning and analyzing oncology or infectious disease trials (Phase I-IV).
• Experience leading statistics for regulatory submissions and answering health authority questions (FDA, EMA).
• Proficiency in statistical software such as SAS or R.
• Strong knowledge of clinical development, study designs, and regulatory guidelines (ICH, FDA, EMA).
• Excellent command of written and spoken English.

Preferred Qualifications

• Experience with advanced statistical methods such as adaptive design or Bayesian approaches.
• Knowledge of special topics including Diagnostics, Biomarkers, PK/PD, PRO, or RWE.
• Proficiency with sample size calculation software like EAST or NQuery.

Benefits

• Competitive remuneration packages determined by role, location, and experience.
• A dynamic and diverse workplace focused on medical innovation.
• Opportunities for meaningful career growth within a mission-driven organization.

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 innovation and scientific excellence.