BioSpace
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, including immunology, oncology, neuroscience, and eye care, and provide products and services in our Allergan Aesthetics portfolio.
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 Include
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.
Ensuring consistency across standard types (e.g., eCRF standards align with TLF standards, SDTM standards align with ADaM standards, etc.).
Developing training materials to the organization on the proper use of standards in pipeline activities.
Communicating ongoing standard development activities across the organization.
Pipeline Responsibilities Include
Providing feedback on CRF design and SDTM datasets to ensure data collection supports regulatory requirements for compliance with CDISC standards (CDASH, SDTM, and ADaM) and AbbVie standard extensions to CDISC.
Reviewing and providing feedback on SDTM Trial Design Domains.
Overseeing the creation of SDTM define.xml, annotated CRF, and Clinical Study Data Review Guides for both FDA and PMDA submissions.
Consulting on conformance issues for SDTM and/or ADaM and working with the study team to resolve problems through data or metadata corrections or 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, driving those improvements to completion.
Qualifications
MS with 8 years of relevant clinical research experience, or
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 is helpful.
Active participation on CDISC teams is preferred.
Experience preparing SDTM and/or ADaM datasets and documentation for regulatory submissions.
Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law. The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting, based on the job grade for this position. Individual compensation paid within this range will depend on many factors, including geographic location, and the Company may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical, dental, vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs.
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.
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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 Include
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.
Ensuring consistency across standard types (e.g., eCRF standards align with TLF standards, SDTM standards align with ADaM standards, etc.).
Developing training materials to the organization on the proper use of standards in pipeline activities.
Communicating ongoing standard development activities across the organization.
Pipeline Responsibilities Include
Providing feedback on CRF design and SDTM datasets to ensure data collection supports regulatory requirements for compliance with CDISC standards (CDASH, SDTM, and ADaM) and AbbVie standard extensions to CDISC.
Reviewing and providing feedback on SDTM Trial Design Domains.
Overseeing the creation of SDTM define.xml, annotated CRF, and Clinical Study Data Review Guides for both FDA and PMDA submissions.
Consulting on conformance issues for SDTM and/or ADaM and working with the study team to resolve problems through data or metadata corrections or 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, driving those improvements to completion.
Qualifications
MS with 8 years of relevant clinical research experience, or
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 is helpful.
Active participation on CDISC teams is preferred.
Experience preparing SDTM and/or ADaM datasets and documentation for regulatory submissions.
Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law. The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting, based on the job grade for this position. Individual compensation paid within this range will depend on many factors, including geographic location, and the Company may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical, dental, vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs.
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.
#J-18808-Ljbffr