Statistical Analyst (Hybrid)

AbbVie; Irvine (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

AbbVie is seeking a Statistical Analyst to drive statistical programming for clinical trials within an integrated R&D environment.

The role interfaces with Statistics, Clinical Data Strategy & Operations and Development Operations, supporting regulatory filings and data visualization efforts.

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

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

Clinical trials experience

SAS programming

ADaM datasets experience

Communication skills

CDISC standards understanding

Drug development knowledge

Education

MS in Statistics or Computer Science (2+ years)

BS in Statistics or Computer Science (4+ years)

Tools

SAS

ADaM

Job 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.

Company Description

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

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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• 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.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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