About this role
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 CollectionData Review RulesSDTM mappingParticipating 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 derivationStudy-level tables, listings, or figuresProduct-level safety analysis displaysEnsuring each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activitiesEnsuring 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 activitiesCommunicate ongoing standard development activities across the organizationPipeline 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 CDISCReview and provide feedback on SDTM Trial Design DomainsSDTM Programming based on SDTM specificationsOversee the creation of SDTM datasets, define.xml, annotated CRF and Clinical Study Data Reviewer’s Guides for both FDA and PMDA submissionsConsult 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 explanationOther 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 useidentifying improvements to the processes and content of standards, and driving those improvements to completion 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 experienceExperience with SDTM programming is required as well as experience with leading development of standards for data collection, tabulation, analysis and/or reportingExperience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissionsExperience with CDASH and active participation in CDISC teams recommendedExperience with ADaM, Analysis Results Metadata, or TLF standards are helpfulFluent language skills in English written as well as spoken are necessary, German language skills are a plusWhat we offer you:
with a diverse work environment where you can have a real impactwith an open corporate culturewith an attractive salarywith an intensive onboarding process with a mentor at your sidewith flexible work models for a healthy work-life balancewith a corporate health management that offers comprehensive health and exercise programswith company social benefitswith a wide range of career opportunities in an international organizationwith top-tier, attractive development opportunitieswith a strong international networkAt multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.
At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.
Any questions? Feel free to email us at [email protected] – We are looking forward hearing from you!
AbbVie setzt sich für Chancengleichheit ein und verpflichtet sich, mit Integrität zu arbeiten, Innovationen voranzutreiben, Leben zu verändern und unserer Gemeinschaft zu dienen. Chancengleichheit bei Arbeitgeber/Veteranen/Behinderten.