Statistical Programmer (Data & Statistical Sciences (DSS))
AbbVieAbout the role
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
- Interface with DSS.
- Serve as an integral project team member in R & D of new pharmaceutical products.
- Analyze & report clinical trial data under direction of Senior Statistical Analyst.
- Provide SAS programming support for clinical trials.
- Develop SAS programs for creation of Analyst Data Models (ADaM), data sets following CDISC standards for either production/validation with creating specifications for structure of ADaM data sets for individual studies.
- Develop SAS programs for creation of Tables, Listings & Figures for either production/validation, also responsible for accuracy of SAS programs by reviewing output, code, & log files.
Qualifications
Education & Experience
Must possess a BS in Statistics, Biostatistics, Computer Science or related field, & 2 years of relevant statistical programming experience. Of experience required, must have 2 years of work experience in each of the following:
- providing SAS programming support for pharmaceutical industry clinical trials;
- coding SAS programs using SAS base;
- utilizing SAS tools SAS/MACROS, SAS/SQL, SAS/GRAPH, & SAS/STAT;
- developing ADaM specifications per CDISC standards;
- developing ADaM datasets in compliance with CDISC standards & developing Tables, Listings, & figures;
- creating documentation for regulatory filings including reviewers’ guides & data definition documents, &
- complying with FDA & EMEA regulatory agencies/ICH guidelines & relevant regulatory requirements.
Alternatively, would accept MS in Statistics, Biostatistics, Computer Science, or related field & 6
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