Manager - Data Standards, SDTM Programming at AbbVie

berlin, Berlin, Germany -

Full Time

Start Date

Immediate

Expiry Date

07 Jan, 27

Salary

45000.0

Posted On

09 Oct, 26

Experience

1 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Medical Practices & Clinics

Description

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

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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

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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

Responsibilities

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