*Please note, this position can be based at our AbbVie location or home-based with travel on site as needed.
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.
The Senior Manager, Safety Statistics provides scientific and strategic input and safety statistics leadership for assigned clinical development projects. A visible and collaborative role, the Senior Manager works in partnership with patient safety, clinical, and regulatory experts to advance medicines to our patients.
- Serve as the Product Safety Team (PST) statistician for one or more clinical development projects. Lead/develop safety statistical strategy for project development and regulatory submission.
- Provide statistical leadership in the safety analysis and reporting for clinical data and ensure appropriate interpretation of safety deliverables in collaboration with other functions.
- Author the Product Safety Statistical Analysis Plans (PSSAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs) and lead the development of safety data integration specifications in accordance with analysis plan.
- Contribute to strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory agencies.
- Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management.
- Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects. Build interdepartmental relationships.
- Lead cross-functional development of output specifications to address pre-planned safety analyses and ad hoc requests. Provide sufficient detail to allow programming implementation and ensure all statistical analyses specified in analysis plans are conducted appropriately.
- Lead development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming and other stakeholders.
- Mentor staff on safety statistical methodology and operations. Gain expertise in innovative safety statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.
- Develop safety strategy for data presentation and inference. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
- Ensure that all applicable regulatory requirements for work processes are met, review regulatory submission documents, and represent DSS in discussions with regulatory agencies.
- Lead development by Safety Statistics of benefit-risk planning and assessment, including ensuring delivery and interpretation of benefit-risk data displays/analyses.
- Lead within-SSG initiatives and represent SSG on cross-functional efforts to implement strategic initiatives that address processes related to monitoring, assessing, interpreting, and reporting safety data.
- Stay current with industry trends and practices related to safety.
- MS (with 8+ years of experience) or PhD (with 4+ years of experience) in Statistics, Biostatistics, or a highly related field.
- High degree of technical competence and excellent communication skills, both oral and written
- Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others
- Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo.
- Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment. Prior experience interacting with regulatory agencies or with supporting regulatory responses is preferred.
- Demonstrate extensive understanding of statistical concepts and methodology for analysis of safety data.
- Some prior experience supporting safety-related projects is preferred (e.g., ISS, benefit-risk assessment, signal detection).
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced