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

AbbVie; Ludwigshafen am Rhein; On-site; EUR 110,000 - 209,000; Full time

Benefits offered by this job

Flexible work models

Mentoring and onboarding

Health benefits

Global network

Job summary

AbbVie is seeking a Manager for Data Standards, SDTM Programming in a hybrid model based in Germany. You will develop SDTM/ADaM standards, align data collection and reporting with CDISC guidelines, and support regulatory submissions.

Responsibilities include SDTM programming, datasets and define.xml creation, and cross-functional collaboration with study teams. A master’s or bachelor’s with extensive experience in clinical research and SDTM is required, with English fluency and German a plus.

Qualifications

• Bachelor’s or Master’s degree with clinical research experience
• Experience with SDTM programming is required
• Experience leading development of data standards for data collection, tabulation, analysis and/or reporting
• Experience documenting SDTM/ADaM datasets and submission deliverables
• Fluent English (written and spoken); German is a plus

Responsibilities

• Develop and define data standards in SDTM/ADaM within therapeutic areas
• Ensure standards align across data collection, CRF design, SDTM, ADaM and CDISC extensions
• Create training materials on standards usage for pipeline activities
• Oversee SDTM datasets, define.xml, annotated CRFs and related submission artifacts
• Provide conformance guidance for SDTM/ADaM and resolve issues with study teams
• Represent AbbVie in industry standards projects and stay updated on CDISC requirements

Skills

SDTM programming

Data standards

CDISC

ADaM

Regulatory submissions

Education

Master's degree (data science/biostatistics/comp sci)

Bachelor's degree (data-related)

Job description

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

• Salary Min: 109500
• Salary Max: 208500
• Workday Global Grade: 18

About AbbVie

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

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
• Experience with CDASH and active participation in CDISC teams recommended
• Experience with ADaM, Analysis Results Metadata, or TLF standards are helpful
• Fluent language skills in English written as well as spoken are necessary, German language skills are a plus

What we offer you:

• 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

At 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?