BioNTech SE
Cambridge, MA, USA
Cambridge, US; Gaithersburg, US; London, United Kingdom; New Jersey, US | full time | Job ID: 9662
Responsibilities:
Provide strategic and scientific leadership across integrated safety and efficacy analyses (ISS/ISE) at the program and platform levels.
Lead programming support for global submission (NDA, BLA, MAA, PMDA), including integrated datasets, TLFs, define.xml, and reviewers’ guides.
Partner with the Head of Statistical Programming to define and execute the global programming strategy, ensuring innovation, quality, and scalability.
Collaborate with clinical development teams to influence analysis planning, interpretation, and data-driven decision-making at the program and platform levels.
Oversight global programming operations, including internal teams and FSP partners, ensuring high-quality deliverables and operational consistency.
Champion advanced technologies (R, Python, cloud automation, AI/ML) to optimize...
