Senior Statistical Analyst - Programming - Oncology (Hybrid) at AbbVie — Irvine, CA

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 Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations.

Responsibilities

Leads the statistical programming activities for projects with lower complexity.

• Leads the statistical programming activities for studies.
• 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.
• Create documentation for regulatory filings including reviewers guides and data definition documents
• Leads the development of standard SAS Macros and participates in the development of standard operating procedures.
• Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts.

Minimum Qualifications:

• Bachelors in Statistics, Computer Science or a related field
• 8+ years of relevant experience in quantitative analysis (or 6+ with a Masters)
• Experience with SAS Programming
• Experience leading programming for clinical trials

Preferred Qualifications:

• Masters Degree in Statistics, Computer Science or related field
• R Programming experience
• Oncology specific experience

Other Required Skills:

• Indepth 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.

• 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.