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About the Role
The Senior Manager, Statistical Programming performs statistical programming and analysis oversight for Oncology Early Development (OED) clinical projects conducted by CROs. This role ensures data integrity and high-quality analysis for oncology first-in-human clinical trials up through clinical proof of concept, and may involve hands-on programming and management of other programmers.
Responsibilities
- 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, adherence to quality processes, and consistency within projects.
- Develops and oversees the development of SAS programs for ADaM data sets following CDISC standards.
- Develops and oversees the development of SAS programs for 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 standard operating procedures.
- Manages, mentors, and creates career development plans for assigned staff.
- Participates in the recruitment and selection of new staff.
Requirements
- 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 orally and in writing.
- Ability to effectively represent the Statistical Programming Organization in cross-functional teams.
- Ability to accurately estimate effort required for project-related programming activities.
Skills
- SAS programming
- CDISC Standards
- Drug development process
- Regulatory filings
- Team leadership
- Project management
- Statistical programming
Location
- US
Work Type
- Full-time
Experience Level
- Senior Manager
- 9+ years relevant experience (MS)
- 11+ years relevant experience (BS)
Education Level
- MS in Statistics, Computer Science or related field
- BS in Statistics, Computer Science or related field
Salary/Compensations
- USD 124500 - USD 236500 - yearly
Benefits
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k)
- Long-term incentive programs
About the Company
- 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.
Equal Opportunity
- 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