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.
Your main responsibilities are: - Work collaboratively with Clinical Development team or CRO to meet project deliverables and timelines for statistical data analysis and reporting
- Independently perform or oversee the production and/or validation of programming deliverables (e.g., analysis datasets, tables, listings) for study reports and integrated summaries
- Anticipate resource needs and works with management to ensure adequate long-term resource allocation within a therapeutical project
- Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with company quality standards, ICH-GCP and/or other international regulatory requirements
- Participate in development of a global programming standard library to enable consistent and efficient project deliverables across portfolios; develop tools for efficient production and verification of derived datasets, e.g., SDTM and ADaM, and TLFs
- Provide functional expertise in the development and implementation of BioNTech´s centralized clinical data repository, clinical data dictionary, and operational data dictionary
- Collaborate with Biostatistics to develop, implement and maintain appropriate statistical applications such as data review and reporting tools
- Provide programming support to the regulatory submissions including data submission package and define.xml development
Open for hire at one of the following locations - Mainz Goldgrube, Cambridge Erie Street, Gaithersburg, London.
What you have to offer: - BSc in Statistics, Mathematics, Computer Science, or related discipline, advanced degree preferred
- 5+ years (3+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting
- Strong competence in statistical programming including SAS/Base, Macro, STAT, GRAPH, SQL, etc.
- Good understanding of FDA, EMA, ICH, and global regulations and guidelines
- Solid knowledge and experience of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
- Oncology or Infectious Disease therapeutic areas and submission experience is preferred
- Project management experience, detail-oriented, and strong organizational and communication skills in English (written and Spoken)
- Ability to work in a fast-paced, dynamic team environment as well as strong analytical and problem solving skills
Benefits for you: BioNTech is committed to the wellbeing of our team members and offers a variety of benefits supporting our diverse employee base. We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.
Please click the link below to review a highlight of our benefits -
https://www.biontech.com/int/en/home/careers/working-at-biontech.html