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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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Key Responsibilities

+ Create specifications for the structure of ADaM data sets for individual studies.

+ Develop SAS programs for creation & validation of ADaM data sets following CDISC standards, & of Tables, Listings & Figures.

+ Ensure accuracy of SAS programs by reviewing code, log & output files.

+ Review output to ensure consistency with output for other activities (CSR, ISS, ISE).

+ Create documentation for regulatory filings including reviewers guides & data definition documents.

+ Participate in development of SAS Macros.

Qualifications

Education & Experience

Must possess a BS or foreign academic equivalent in Statistics, Biostatistics, Computer Science or a related field & 2 years of statistical programming experience analyzing clinical trial data in the pharmaceutical industry. Of experience required, must have 2 years of work experience in the following:

+ developing, reviewing & executing code using SAS Enterprise Guide &/or SAS Studio;

+ performing programming tasks including data processing & manipulation using SAS BASE, data analysis using SAS STAT, & data reporting using SAS ODS;

+ using SAS macro variables & macro functions including debugging the macro;

+ developing & validating programming code for derivation of key variables in Trial Design SDTM domains;

+ developing & validating ADaM datasets in compliance with CDISC standards & developing Tables, Listings, & Figures;

+ developing & validating programming code using SAS procedures to implement statistical methodologies for analysis of categorical & continuous variables including linear regression, categorical data analysis, survival analysis, & significance testing;

+ creating or reviewing documentation for regulatory filings including reviewers’ guides & data definition documents; &

+ complying with FDA, EMA, & other regulatory agencies/ICH guidelines & relevant regulatory requirements.

Alternatively, would accept a MS in Statistics, Biostatistics, Computer Science or a related field or foreign academic equivalent, & 6 months of statistical programming experience. Of experience required, must have 6 months in each of i. through viii.

Experience may be gained concurrently. Any suitable combination of education, training or experience is acceptable.

Additional Information

Salary Range: $92,820.00 - $118,500.00 per year.

Apply online at https://careers.abbvie.com/en. Refer to Req ID: REF38574A

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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 and long-term incentive programs.

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

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