Job description
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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
The senior manager, Statistical Programming performs statistical programming and analysis oversight for OED (Oncology Early Development) clinical projects conducted by CROs. This individual is responsible for overseeing several compounds/indications on all statistical programming related tasks delivered by CROs. The goal is to ensure data integrity and high quality of all the analysis for oncology first in human clinical trials up through clinical proof of concept. This individual also performs hands on programming to validate analysis datasets and TLFs delivered by CRO and support in-house studies for full set of analysis tasks. This individual may need to manage other regular or contract statistical programmers.
•Leads the statistical programming activities for one or more compounds/indications or a therapeutic area.
•Manages a team of statistical programmers and the resource planning for their assigned projects.
•Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
•Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
•Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
•Ensures consistency of ADaM data sets for individual studies and integrated data.
•Creates documentation for regulatory filings including reviewers guides and data definition documents.
•Leads the development of standard SAS Macros and the development of standard operating procedures.
•Manages, mentors and creates career development plans for assigned staff.
•Participates in the recruitment and selection of new staff.
Qualifications
- •MS in Statistics, Computer Science or a related field with 9+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience.
•Minimum of 2 years experience leading a team of statistical programmers.
•In-depth understanding of SAS programming concepts and techniques related to drug development.
•In-depth understanding of CDISC Standards.
•In-depth understanding of the drug development process, including experience with regulatory filings.
•Ability to communicate clearly both oral and written.
•Ability to effectively represent the Statistical Programming Organization in cross functional teams.
•Ability to accurately estimate effort required for project related programming activities.
Key Stakeholders
• Directors of Statistics
• Data Scientists
• Medical Writers
• Regulatory Publishers
• Clinical Project Managers
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 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.
This job is eligible to participate in our long-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 a particular 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
