Remote Senior Analyst, Data Standards

Description:

• The Senior Data Standards Analyst within Clinical Data and Reporting Standards contributes to the development of data and reporting standards in support of AbbVie’s portfolio of clinical trials and ensures AbbVie’s conformance to CDISC standards and industry best practices.
• This role will focus on CDASH and SDTM standards within the assigned therapeutic area(s).
• Standards Development responsibilities include actively participating with a cross-functional team of subject matter experts to define one or more types of standards within the assigned therapeutic areas, such as SDTM mapping, data collection, and data review rules.
• The analyst will also participate in defining ADaM mapping and derivation, study-level tables, listings, or figures, and product-level safety analysis displays.
• It is essential to ensure each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities.
• The analyst must ensure consistency across standard types, educate the organization on the proper use of standards in pipeline activities, and communicate ongoing standard development activities across the organization.
• Pipeline responsibilities may include creating, reviewing, and providing feedback on SDTM Mapping Specifications and Trial Design Domains, providing feedback on CRF design and SDTM datasets, overseeing the creation of SDTM define.xml, annotated CRF, and Clinical Study Data Reviewer’s Guides for both FDA and PMDA submissions, and consulting on conformance issues for SDTM and/or ADaM.
• Other responsibilities include representing AbbVie’s interests in industry standards development projects, staying current with industry standards such as CDISC, and identifying improvements to the processes and content of standards.

Requirements:

• This is a remote opportunity that can be hired anywhere in the US.
• Candidates must have experience leading the development of standards for data collection, tabulation, analysis, and/or reporting.
• Experience with SDTM and CDASH is required.
• Active participation in CDISC teams is preferred.
• Candidates should have experience preparing SDTM and/or ADaM datasets and documentation for regulatory submissions.
• Experience with standards related to eye care, neuroscience, or medical aesthetics is helpful.
• Experience with standards related to devices is also helpful.
• Familiarity with ADaM, Analysis Results Metadata, or TLF standards is beneficial.
• Education and experience requirements include a Master's degree with 6 years of relevant clinical research experience, or a Bachelor's degree with 8 years of relevant clinical research experience.

Benefits:

• AbbVie offers a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and a 401(k) plan to eligible employees.
• This job is eligible to participate in AbbVie's short-term incentive programs.
• The compensation range for this role will depend on various factors including geographic location, and the company may ultimately pay more or less than the posted range.