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Become a member of the BioNTech Family! As a part of our team of more than 5.000 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. Director Statistical Programming Implementation of global Statistical Programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency. Support the development and implementation of a global programming ecosystem to enable successful project deliverables Participate in the development and implementation of centralized data warehouse Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables Develop innovative solutions to standardize, automate and optimized efficiency and quality Develop tools for efficient verification of derived datasets, e.g., SDTM and ADaM, and TLFs Build a team of programmers to support ongoing pipeline expansion Generate ad hoc data sets and TLFs on ongoing basis Open for hire at one of the following locations - Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube. - Job ID: 3222 BSc or MSc in Statistics, Mathematics, Computer Science or related subjects 10+ years of experience in the pharmaceutical industry and/or CRO Excellent knowledge of Statistical Programming in SAS including Base, Macro, STAT, GRAPH, SQL Solid understanding of FDA, EMA, ICH and global regulations and industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards Expertise in the requirements and technology required to support electronic submissions Experience in leading submissions and managing people Oncology or Infectious Disease therapeutic areas and submission experience is preferred Strong leadership and project management skills as well as proficiency in English (spoken and written) BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate's qualifications and experience. Click here to find out more about what we do, the careers we offer and also the benefits we provide. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
