Clinical Data Scientist: SAS, ADaM & CDISC in Pharma

AbbVie Inc.; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

AbbVie is seeking a Statistical Analyst to join our research and development efforts in Irvine, CA. The role focuses on analyzing and reporting clinical trial data with minimal supervision for routine tasks and more guidance for complex activities.

The candidate will lead routine statistical programming, create regulatory documentation, and develop SAS macros while ensuring ADaM data sets adhere to CDISC standards. Strong communication and drug development knowledge are essential.

Qualifications

• MS in Statistics, Computer Science or a related field with 2+ years of relevant experience.
• BS in Statistics, Computer Science or a related field with 4+ years of relevant experience.
• Experience in pharmaceutical clinical trials.
• Experience creating and reviewing ADaM datasets for analysis.
• Preferred: ability to support efficacy analyses across clinical development phases.

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

Skills

SAS programming

ADaM datasets

CDISC standards

Communication skills

Drug development knowledge

Regulatory documentation

Education

MS in Statistics/CS or related field

BS in Statistics/CS or related field

Job description

AbbVie is seeking a Statistical Analyst to join our research and development efforts in Irvine, CA. The role focuses on analyzing and reporting clinical trial data with minimal supervision for routine tasks and more guidance for complex activities.

The candidate will lead routine statistical programming, create regulatory documentation, and develop SAS macros while ensuring ADaM data sets adhere to CDISC standards. Strong communication and drug development knowledge are essential.