Statistical Analyst - ADaM Programming (Hybrid)

SmartRecruiters, Inc.; Irvine (CA); Hybrid; USD 85,000 - 162,000; Full time

Job summary

AbbVie in Irvine, CA is seeking a Statistical Analyst for ADaM programming in a hybrid role. You will lead SAS programming activities for routine studies, develop ADaM datasets and create regulatory documentation, while collaborating with Statistics and Clinical Data Strategy teams.

The role requires 2+ years (MS) or 4+ years (BS) in stats/compsci, pharma trials, SAS proficiency, and CDISC ADaM experience. Competitive compensation is disclosed and a comprehensive benefits package is offered.

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
• 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

Experience in pharmaceutical trials

SAS programming

ADaM datasets experience

Oral and written communication

Education

MS in Statistics / Computer Science or related

BS in Statistics / Computer Science or related

Tools

SAS

Job description

Statistical Analyst - ADaM Programming (Hybrid)

• Full-time
• Salary Min: 84500
• Salary Max: 162000
• Workday Global Grade: 16
• Compensation: USD 84,500 - USD 162,000 - yearly

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.

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 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.

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'ssole and absolute discretion 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.