Manager, Data Standards - Hybrid
AbbVieGreat Lakes, IL, US17 hours ago
Job type
- Full-time
Job descriptionActively 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 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 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 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 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 are helpful Active participation in CDISC teams preferred Experience with preparing SDTM and / or ADaM datasets and documentation for regulatory submissions 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 we 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 will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process. If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks.
Job Title : Manager, Clinical Data And Reporting Standards
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.
- 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.
The Manager, Clinical Data And Reporting Standards (CDARS) proactively participates in the development of data and reporting standards in support of AbbVie's portfolio of clinical trials, and ensuring AbbVie's conformance to CDISC standards and industry best practices. This role implements the strategy and framework for governance of standards as set by the Head and Associate Directors of CDARS, and actively engages in deployment of next generation process and technology.
Standards Development responsibilities include :
Pipeline responsibilities include :
Other responsibilities include :
Qualifications :
Additional Information :
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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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more : abbvie.com / join-us / reasonable-accommodations.html
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Manager Data Hybrid • Great Lakes, IL, US
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