Job
- Level
- Lead
- Location
- Ludwigshafen am Rhein
- Working Model
- Hybrid, Onsite
- Job Field
- Data
- Employment Type
- Full Time
- Contract Type
- Permanent employment
Job Summary
In this role, you will develop data standards for clinical studies, oversee SDTM dataset creation, and ensure compliance with regulatory requirements and CDISC standards.
Your role in the 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 or 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
- Überwachen Sie die Erstellung von SDTM-Datensätzen, define.xml, annotierten CRF und Clinical Study Data Reviewer's Guides für sowohl FDA- als auch PMDA-Einreichungen
- 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,
- keeping up-to-date 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
This text has been machine translated. Show original
Our expectations of you
Education
- 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
Qualifications
- This is how you make a difference:
- Fluent language skills in English, both written and spoken, are necessary; German language skills are a plus.
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
- Experience with CDASH and active participation in CDISC teams recommended
- Experience with ADaM, Analysis Results Metadata, or TLF standards are helpful
This text has been machine translated. Show original
What we offer
- 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
This text has been machine translated. Show original
Topics You Will Work On
Job Locations
About Your Employer
AbbVie Deutschland GmbH & Co. KG
AbbVie is a global biopharmaceutical company that was founded in 2013 after separating from Abbott Laboratories. The company's mission is to use its expertise, dedicated staff, and unique approach to innovation to develop and market advanced therapies to treat some of the world's most complex and serious diseases.
Description
- Company Size
- 250+ Employees
- Company Type
- Established Company
- Working Model
- Hybrid, Onsite
- Industry
- Pharmaceutical Sector, Chemical Industry, Biotech, Science, Research
Manager - Data Standards, SDTM Programming
- Location
- Ludwigshafen am Rhein
- Working Model
- Hybrid, Onsite
- Diversity
- Open for all genders
