Statistical Analyst - ADaM Programming (Hybrid)

Statistical Analyst - ADaM Programming (Hybrid)

Irvine, CA

Function: Research & Development Work location type: Hybrid Job Type: Full-time Job ID: R00150443

Company Description About AbbVie 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.

Job Description The Statistical Analyst is an integral role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data without supervision for routine activities and with supervision for more complex activities. The Statistical Analyst interfaces with Statistics, Clinical Data Strategy & Operations and Development Operations.

Responsibilities

• Leads the statistical programming activities for routine studies.
• Create documentation for regulatory filings including reviewers guides and data definition documents
• Participate in the development of standard SAS Macros, as well as, presenting information on existing Macros
• Produce dynamic and static data visualizations to communicate quantitative analyses.
• Develop SAS programs for the creation of ADaM data sets following CDISC standards.
• Develop SAS programs for the creation of Tables, Listings and Figures.
• Validation of ADaM data sets. Validation of Tables, Listings and Figures.
• Create specifications for the structure of ADaM data sets for individual studies and integrated data

Qualifications

Minimum Qualifications:

• MS in Statistics, Computer Science or a related field with 2+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 4+ years of relevant experience.
• Experience in pharmaceutical clinical trials
• Demonstrated practical understanding of SAS programming related to drug development.
• Experience creating and reviewing ADaM datasets for analysis

Preferred Qualifications:

• Demonstrated ability to support efficacy analyses across clinical development phases and therapeutic areas.

Other Required Skills:

• Ability to communicate clearly both oral and written.
• Basic understanding of CDISC Standards.
• Basic understanding of the drug development process.