Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

The Manager, Clinical Data and Reporting Standards (CDARS) proactively participates in the development of data and reporting standards for clinical trials, ensuring conformance to CDISC standards and industry best practices. This role implements the strategy and framework for governance of standards and engages in the deployment of next-generation processes and technology.

Responsibilities

• Participating with a cross-functional team to define standards for data collection, data review rules, and SDTM mapping within assigned therapeutic areas.
• Defining standards for ADaM mapping and derivation, study-level tables, listings, or figures, and product-level safety analysis displays.
• Ensuring each standard is clearly defined with appropriate documentation of assumptions and decisions.
• Ensuring consistency across standard types (e.g., eCRF standards align with TLF standards, SDTM standards align with ADaM standards).
• Developing training materials for the organization on the proper use of standards.
• Communicating ongoing standard development activities across the organization.
• Providing feedback on CRF design and SDTM datasets to ensure compliance with regulatory requirements and CDISC standards.
• Reviewing and providing feedback on SDTM Trial Design Domains.
• Performing SDTM Programming based on SDTM specifications.
• Overseeing the creation of SDTM datasets, define.xml, annotated CRF, and Clinical Study Data Reviewer’s Guides for regulatory submissions.
• Consulting on conformance issues for SDTM and/or ADaM and resolving problems with study teams.
• Representing AbbVie’s interests in industry standards development projects.
• Staying current with industry standards such as CDISC and related regulatory requirements.
• Identifying and driving improvements to the processes and content of standards.

Requirements

• MS with 8 years of relevant clinical research experience, or BS with 10 years of relevant clinical research experience.
• Experience with SDTM is required.
• Experience 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.

Skills

• SDTM
• CDASH
• ADaM
• Analysis Results Metadata
• TLF standards
• CDISC

Experience Level

• Manager

Education Level

• MS
• BS

Salary/Compensations

• USD 109500 - USD 208500 - yearly

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Eligible to participate in long-term incentive programs

About the Company

• 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 and neuroscience - and products and services in our Allergan Aesthetics portfolio.
• For more information about AbbVie, please visit us at www.abbvie.com.
• Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Equal Opportunity

• 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