Poslané v: Iné v Rhineland-Palatinate | Posted: |
Join our team of pioneers! 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. Associate Director Statistical Programming (Infectious Diseases) Work with Director Statistical Programming to implement 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 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 work with management to ensure adequate long-term resource allocation within a therapeutical project Ensure quality control (QC) 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 Collaborate with Biostatistics to develop, implement and maintain appropriate statistical applications such as data review and reporting tools and provide programming support to the regulatory submissions including data submission package and define.xml development Provides programming support to the regulatory submissions including data submission package and define.xml development Bachelor's degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred 10+ years (5+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting Excellent knowledge of statistical programming including SAS/Base, Macro, STAT, GRAPH, SQL, etc. Solid 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 Strong interpersonal skills in addition to exceptional English written and oral communication skills, combined with the need to work closely with CROs, investigators, consultants, and team members across functions Project management experience and strong analytical and problem solving skills Ability to work in a fast-paced, dynamic, and a team environment 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 ans 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.
