Statistical Analyst - ADaM Programming (Hybrid)

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

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 programmingrelated to drug development.
• Experience creating and reviewingADaM 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 orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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