Senior Statistical Analyst

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

• Perform statistical programming activities for all assigned Phase I-IV clinical studies sponsored by AbbVie and its partners.

• Perform statistical programming for clinical studies, integrated summaries, and in support of responses to requests from regulatory authorities.

• Provide programming and documentation support for multiple studies with high quality.

• Utilize experience in SAS and Linux.

• Review statistical analysis plans for all assigned studies and integrated summaries in conjunction with program lead and provide comments to study biostatistician.

• Utilize knowledge of statistical methodology in clinical trials, FDA regulations and CDISC standards.

• Create ADaM data set specifications for all assigned studies and integrated summaries.

• Ensure study analysis is consistent with standard templates and specifications.

• Contribute to submission support.

• Contribute to development of new standard templates.

• Participate in development of standard operating procedures and support documents related to Statistical Programming processes.

• Support urgent regulatory agency requests.

• Participate in a Statistical Programming process improvement initiative.

• Manage timelines and ensure good communication with CROs/FSPs and internal programmers.

• Oversee programming tasks for a single study.

• Project management and conduct high level review of deliverables provided by CRO/FSP to ensure good quality and accuracy.

Qualifications

Must possess a Bachelor's degree or foreign academic equivalent in Statistics, Mathematics, Engineering or a highly related field of study with at least 5 years of experience.

In the alternative, employer will accept a Master's degree or foreign academic equivalent in the aforementioned fields with at least two 2 years of related experience.

Each educational alternative with at least 2 years of experience in the following:

• experience in SAS and Linux;
• knowledge of statistical methodology in clinical trials, FDA regulations and CDISC standards;
• project management and conducting high level review of deliverables provided by CRO/FSP to ensure good quality and accuracy.

Employer will accept any suitable combination of education, training or experience related to the job opportunity.

100% telecommunicating permitted.

Salary Range: $136,500 - $157,500 per year.