Statistical Programmer

AbbVie; North Chicago (IL); In loco; USD 85.000 - 110.000; Tempo pieno

Descrizione del lavoro

AbbVie seeks a Statistical Programmer to join the R&D team in the development and analysis of clinical trial data. The role involves creating regulatory documentation, developing SAS macros, and consolidating diverse data sources to produce analysis-ready datasets in ADaM format following CDISC standards.

You will perform exploratory analyses, generate visualizations, and validate ADaM datasets and TLFs, collaborating with statisticians, data strategy, medical writing, and regulatory teams.

Competenze

• MS in Statistics, Computer Science or a related field with 0+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 2+ years of relevant experience.
• Demonstrated practical understanding of SAS programming or NONMEM concepts and techniques.
• Ability to communicate clearly both oral and written.

Mansioni

• Create documentation for regulatory filings including reviewers guides and data definition documents.
• Participate in the development of standard SAS Macros.
• Consolidate heterogeneous data sources (e.g. clinical study databases, external databases, real-world data) to prepare analysis-ready data sets within a defined quality control process supporting a particular study.
• Perform exploratory data analyses and visualizations in interaction with the clinical pharmacologist or pharmacometrician.
• 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.

Conoscenze

SAS programming

NONMEM concepts

Communication

Formazione

MS in Statistics/CS/related

BS in Statistics/CS/related

Strumenti

SAS

CDISC ADaM

TLFs (Tables, Listings & Figures)

Descrizione del lavoro

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 Programmer is an integral project team member in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data under the direction and oversight of a Senior Statistical Analyst. The Statistical Programmer interfaces with key stakeholders (i.e. Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and Development Operations.)

Responsibilities

• The Statistical Programmer will:
• Create documentation for regulatory filings including reviewers guides and data definition documents.
• Participate in the development of standard SAS Macros.
• Consolidate heterogeneous data sources (e.g. clinical study databases, external databases, real-world data) to prepare analysis-ready data sets within a defined quality control process supporting a particular study.
• Perform exploratory data analyses and visualizations in interaction with the clinical pharmacologist or pharmacometrician.
• 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.

Qualifications

• MS in Statistics, Computer Science or a related field with 0+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 2+ years of relevant experience.
• Demonstrated practical understanding of SAS programming or NONMEM concepts and techniques.
• Ability to communicate clearly both oral and written.

Additional Information

• 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.