Job
- Level
- Lead
- Ort
- Ludwigshafen am Rhein
- Arbeitsmodell
- Hybrid, Onsite
- Job Feld
- Data
- Anstellung
- Vollzeit
- Vertragsart
- Unbefristetes Dienstverhältnis
Job Zusammenfassung
In dieser Position entwickelst du Datenstandards für klinische Studien, überwachst die SDTM-Dataset-Erstellung und gewährleistest die Konformität mit regulatorischen Anforderungen und CDISC-Standards.
Deine Rolle im Team
- 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
Unsere Erwartungen an dich
Ausbildung
- 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
Qualifikationen
- This is how you make a difference:
- Fluent language skills in English written as well as spoken are necessary, German language skills are a plus
Erfahrung
- 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
- Experience with CDASH and active participation in CDISC teams recommended
- Experience with ADaM, Analysis Results Metadata, or TLF standards are helpful
Unser Angebot
- with a diverse work environment where you can have a real impact
- with an open corporate culture
- with an attractive salary
- with an intensive onboarding process with a mentor at your side
- with flexible work models for a healthy work-life balance
- with a corporate health management that offers comprehensive health and exercise programs
- with company social benefits
- with a wide range of career opportunities in an international organization
- with top-tier, attractive development opportunities
- with a strong international network
Themen mit denen du dich im Job beschäftigst
Job Standorte
Das ist dein Arbeitgeber
AbbVie Deutschland GmbH & Co. KG
AbbVie ist ein weltweit führender Anbieter von biopharmazeutischen Produkten, der 2013 durch die Trennung von Abbott Laboratories entstanden ist. Unser Ziel ist es, unsere Expertise, unsere people-first-Strategie und unser innovatives Denken zur Entwicklung und zum Vertrieb besonderer Therapien zu nutzen, mit denen wir some of the world's most complex and serious diseases bekämpfen können.
Description
- Unternehmensgröße
- 250+ Employees
- Unternehmenstyp
- Etablierte Firma
- Arbeitsmodell
- Hybrid, Onsite
- Branche
- Pharma, Chemie, Biotech, Wissenschaft, Forschung
Manager - Data Standards, SDTM Programming
- Ort
- Ludwigshafen am Rhein
- Arbeitsmodell
- Hybrid, Onsite
- Diversität
- Für alle Personen geeignet (m/w/d)
