AbbVie
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Manager, Data Standards - Hybrid
role at
AbbVie
Base Pay Range $106,500.00/yr – $202,500.00/yr
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
Job Description This is a hybrid based position. Candidates must be local and work out of North Chicago, IL; Florham Park, NJ; San Francisco, CA or Irvine, CA.
Standards Development Responsibilities
Actively participating with a cross-functional team of subject matter experts to define one or 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
Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that supports 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
Oversee the creation of SDTM 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
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
Qualifications
MS with 8 years of relevant clinical research experience
BS with 10 years of relevant clinical research experience
Experience leading development of standards for data collection, tabulation, analysis and/or reporting
Experience with SDTM is required
Experience with CDASH is highly recommended
Experience with ADaM, Analysis Results Metadata, or TLF standards are helpful
Active participation in CDISC teams preferred
Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions
Seniority Level
Mid-Senior level
Employment Type
Full-time
Job Function
Information Technology
Pharmaceutical Manufacturing and Biotechnology Research
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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Manager, Data Standards - Hybrid
role at
AbbVie
Base Pay Range $106,500.00/yr – $202,500.00/yr
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
Job Description This is a hybrid based position. Candidates must be local and work out of North Chicago, IL; Florham Park, NJ; San Francisco, CA or Irvine, CA.
Standards Development Responsibilities
Actively participating with a cross-functional team of subject matter experts to define one or 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
Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that supports 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
Oversee the creation of SDTM 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
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
Qualifications
MS with 8 years of relevant clinical research experience
BS with 10 years of relevant clinical research experience
Experience leading development of standards for data collection, tabulation, analysis and/or reporting
Experience with SDTM is required
Experience with CDASH is highly recommended
Experience with ADaM, Analysis Results Metadata, or TLF standards are helpful
Active participation in CDISC teams preferred
Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions
Seniority Level
Mid-Senior level
Employment Type
Full-time
Job Function
Information Technology
Pharmaceutical Manufacturing and Biotechnology Research
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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