Company Description
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
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 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.
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
Qualifications
Minimum Qualifications:
-
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
Preferred Qualifications:
-
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.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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 atthe time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors includinggeographic 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.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested,and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to aparticular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion,consistent with applicable law.
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
