Senior Statistical Analyst - Programmer (Hybrid)

Responsibilities

• Leads 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
• Participating 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

Requirements

• 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 speicifications
• Knowledge of R or Ai is not required but can be a plus.
• Other Required Skills:
• 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.
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• 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.
• 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
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
• https://www.abbvie.com/join-us/reasonable-accommodations.html

Benefits

Additional Information

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

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