Manager Statistical Programming

Responsibilities

• Collaborate with Clinical Development teams and CROs to meet project deliverables and timelines for statistical data analysis and reporting
• Independently perform or oversee the production and validation of programming deliverables, including analysis datasets, tables, listings, and figures
• Ensure quality control (QC) of all technical activities in accordance with company standards, ICH-GCP, and international regulatory requirements
• Anticipate resource needs and work with management to ensure adequate long-term allocation within therapeutic projects
• Participate in the development of a global programming standard library and tools for efficient production of SDTM, ADaM, and TLFs
• Provide programming support for regulatory submissions, including data submission packages and define.xml development
• Collaborate with Biostatistics to develop and maintain statistical applications such as data review and reporting tools

Requirements

• Bachelor's degree in Statistics, Mathematics, Computer Science, or a related discipline
• 5+ years of experience in the pharmaceutical industry, a CRO, or a clinical research setting (3+ years if holding an advanced degree)
• Strong proficiency in statistical programming, specifically SAS (Base, Macro, STAT, GRAPH) and SQL
• Solid knowledge of CDISC standards and industry standards for clinical study data and reporting
• Thorough understanding of FDA, EMA, ICH, and other global regulatory guidelines

Preferred Qualifications

• Advanced degree in a relevant quantitative field
• Experience in Oncology or Infectious Disease therapeutic areas
• Previous experience with regulatory submission processes
• Proven project management experience

Benefits

• Competitive remuneration packages based on role, location, and experience
• A commitment to team member wellbeing and a diverse, inclusive work environment

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 a shared passion for advancing medicine.