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Associate Director* Statistical Programming

Become a member of the BioNTech Family!

As a part of our team of more than 4.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.Your main responsibilities are:
  • Support the development and implementation of a global programming ecosystem to enable successful project deliverables
  • Participate in the development and implementation of BioNTech’s centralized data warehouse
  • Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables
  • Establish innovative solutions to standardize, automate and optimize efficiency and quality to meet business needs and meet regulatory requirements
  • Set up tools for efficient verification of derived datasets, e.g. SDTM and ADaM, and TLFs
  • Generate ad hoc data sets and TLFs on ongoing basis
  • Author and review programming specifications and validation
  • Collaborate with Biostatistics to develop, implement and maintain appropriate statistical applications such as data review and reporting tools and work together with cross-functionally with teams from Clinical Development, Clinical Operations, Regulatory Affairs, and others to meet project deliverables and timelines for statistical data analysis and reporting
What you have to offer:
  • BSc or MSc in Statistics, Mathematics, Computer Science or related subject
  • 6 years of experience in a pharmaceutical industry, CRO or another clinical research setting
  • Excellent knowledge of statistical programming in SAS including Base, macro, STAT, GRAPH, SQL
  • Solid understanding of FDA, EMA, ICH, and global regulations and guidelines as well as strong knowledge of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
  • Substantial awareness of the drug development process from early- to late-stage development and submission
  • Expertise in the requirements and technology required to support electronic submissions
  • Experience in leading submissions and managing people
Benefits for you.
  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.
Refer code: 682204. BioNTech SE - Der vorherige Tag - 2023-10-03 16:20

BioNTech SE

Mainz

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