Statistical Programmer

AbbVie Inc.; Irvine (CA); In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

AbbVie Inc. is seeking a Statistical Programmer to support R&D analytics for clinical trials. You will analyze and report data under supervision, interfacing with Statistics, Clinical Data Strategy & Operations, Medical Writing, and Regulatory teams.

The role emphasizes developing ADaM data sets, creating Tables, Listings and Figures, and building regulatory-grade documentation for filings. Strong communication is essential to success.

Competenze

• MS in Statistics, Computer Science or a related field with 0+ years of relevant experience, or BS with 2+ years of 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.
• Contribute to development of SAS Macros and standards.
• Consolidate heterogeneous data sources to prepare analysis-ready data sets and perform exploratory analyses.
• Develop SAS programs for ADaM data sets, Tables, Listings and Figures; validate outputs.

Conoscenze

SAS programming

NONMEM concepts

Communication skills

Formazione

MS in Statistics, Computer Science or related field

BS in Statistics, Computer Science or related field

Strumenti

SAS Macros

SAS

Descrizione del lavoro

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 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.
• The Programmer will:
  - 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

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, anddeterminate.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