Senior Statistical Analyst (Remote) - Pipeline

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

The Senior Statistical Analyst is a key 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 and leading the statistical programming activities for clinical studies and projects with lower complexity. The Senior Statistical Analyst interfaces with key stakeholders (i.e. Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and Development Operations.)

Responsibilities:

• Leads the statistical programming activities for projects with lower complexity.

• Leads the statistical programming activities for studies.

• Create documentation for regulatory filings including reviewers guides and data definition documents.

• Leads the development of standard SAS Macros.

• Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts.

• 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, Tables, Listings and Figures.

• Create specifications for the structure of ADaM data sets for individual studies and integrated data.

• Participates in the development of standard operating procedures.

The Senior Statistical Analyst roles have the flexibility to be based remotely within the US.

Qualifications

• MS in Statistics, Computer Science or a related field with 5+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 7+ years of relevant experience.

• In-depth understanding of SAS programming concepts and techniques related to drug development.

• Fundamental understanding of CDISC Standards.

• Fundamental understanding of the drug development process, including experience with regulatory filings.

• Ability to communicate clearly both oral and written.

• Ability to accurately estimate effort required for study related programming activities.

Additional Information

Applicable only to applicants