Manager - Data Standards, SDTM Programming (Hybrid) (all genders) (full-time, regular)

Manager - Data Standards, SDTM Programming (Hybrid) (all genders) (full-time, regular) Vollzeit About AbbVie AbbVie hat es sich zur Aufgabe gemacht, innovative Medikamente und Lösungen zu entwickeln und bereitzustellen, mit denen schwerwiegende Gesundheitsprobleme von heute gelöst und die medizinischen Herausforderungen von morgen bewältigt werden können. Wir sind bestrebt, das Leben der Menschen in verschiedenen wichtigen therapeutischen Bereichen wie Immunologie, Onkologie und Neurowissenschaften sowie in Produkten und Dienstleistungen in unserem Allergan Aesthetics-Portfolio bemerkenswert zu beeinflussen. Für weitere Informationen über AbbVie besuchen Sie uns bitte auf www.abbvie.com . Folgen Sie @abbvie auf LinkedIn, Facebook, Instagram, X und YouTube. Stellenbeschreibung Welcome to AbbVie! As part of an international company with 57,000 employees worldwide and around 3,500 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place! Together, we break through – as Manager - Data Standards, SDTM Programming (Hybrid) (all genders) Make your mark: Standards Development responsibilities include : Actively participating with a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas: Data Collection Data Review Rules SDTM mapping Participating in a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas: ADaM mapping and derivation Study-level tables, listings, or figures Product-level safety analysis displays Ensuring each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities Ensuring consistency across standard types (e.g. eCRF standards align with TLF standards, SDTM standards align with ADaM standards, etc.) Develop training materials to the organization on the proper use of standards in pipeline activities Communicate ongoing standard development activities across the organization Pipeline responsibilities include: Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and AbbVie standard extensions to CDISC Review and provide feedback on SDTM Trial Design Domains SDTM Programming based on SDTM specifications Oversee the creation of SDTM datasets, define.xml, annotated CRF and Clinical Study Data Reviewer’s Guides for both FDA and PMDA submissions Consult on conformance issues for SDTM and/or ADaM and work with the study team to resolve the problem either by correcting the data or metadata, or by providing an appropriate explanation Other responsibilities include: representing AbbVie’s interests in industry standards development projects, staying current with industry standards such as CDISC, and the regulatory requirements related to their use identifying improvements to the processes and content of standards, and driving those improvements to completion Qualifikationen This is how you make a difference: University degree in computer science, data science, biology or statistics and master’s degree with 8 years or bachelor’s degree with 10 years of relevant clinical research experience Experience with SDTM programming is required as well as experience with leading development of standards for data collection, tabulation, analysis and/or reporting Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions