Senior Statistical Analyst - Programmer; Hybrid

Job Description

The role of the Senior Statistical Analyst is to perform statistical programming activities for all assigned Phase I-IV clinical studies sponsored by Abb Vie and its partners. This position performs statistical programming for clinical studies, integrated summaries, and support of responses to requests from regulatory authorities. This position can serve as a study lead for an assigned study.

• Lead the statistical programming activities and provide programming and documentation support for multiple studies with high quality.
• Review statistical analysis plans for all assigned studies and integrated summaries in conjunction with program lead and provide comments to study biostatistician.
• Create ADaM data set specifications and data set for all assigned studies and integrated summaries.
• Ensure study analysis is consistent with standard templates and specifications.
• Contribute to submission support and support urgent regulatory agency requests.
• Follow timelines for assigned study tasks.
• Coordinate own task assignments.
• Participate in a Statistical Programming process improvement initiative.
• Manage timelines and ensure good communication with CROs/FSPs, internal programmers, statistics, data management, medical writing, regulatory publishing and clinical operations.
• Oversee programming tasks for a single study.
• Conduct high level review of deliverables provided by CRO/FSP to ensure good quality and accuracy.

• Degree in Statistics, Mathematics, or Engineering.
• 6+ years of relevant experience (with MS) or 8+ years of relevant experience (with BS).
• Experience with SAS programming related to drug development.
• Experience with regulatory filings.
• Experience adhering to CDISC standards and creating and reviewing ADaM specifications.

• Knowledge of R or AI is not required but can be a plus.

• 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.
• 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.

Abb Vie 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.

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