Manager, Statistical Programming (Safety)
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The Manager of Statistical Programming (Safety) is a strategic role in the emerging field of safety science providing programming support and technical guidance to team of Statistical Programmers in the research, development and safety assessment of pharmaceutical products. This role is directly responsible for leading the statistical programming activities for development and maintenance of integrated clinical safety data for one or more compounds/indications or therapeutic areas in early development. The Manager of Statistical Programming (Safety) must effectively interface with Statistics, Data Sciences, Pharmacovigilance and Patient Safety, Data Analytics, Medical Writing, Regulatory Publishing and Clinical Operations.
- Leads the statistical programming activities for two or more compounds/indications or therapeutic areas in early development in creating integrated safety data sets to support safety monitoring, signal detection, clinical safety analytics and regulatory submissions
- Leads a team of statistical programmers and manages the resource planning for assigned staff.
- Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
- Develops and oversees the development of SAS programs, Product safety data integration plan, metadata, ADaM data sets following CDISC standards and Tables, Listings and Figures (TLFs).
- Ensures consistency of ADaM data sets and analysis interpretations 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 participates in the development of standard operating procedures and cross-functional process improvement initiatives
- Provides oversight and mentoring of assigned Statistical Programmers, Statistical Analysts and Senior Statistical Analysts.
- MS in Statistics, Computer Science or a related field with 8+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 10+ years of relevant experience.
- Previous 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 and creation of pooled data for integrated summary of safety analysis or for safety monitoring
- Experience in leading statistical programming activities supporting IB, DSUR, PSUR, Integrated Summary of Safety, Annual Safety Reports and/or other safety analysis.
- Experience in developing data transformation automation tools and programming languages such as R, Python is preferable.
- 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.
Significant Work Activities
Yes, 5 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.