AbbVie is looking to solve serious health issues today and address the medical challenges of tomorrow by discovering and delivering innovative medicines and solutions, and the Senior Manager, Statistics will provide statistical leadership to support the research and development organization for assigned projects.
Requirements
- MS (with 8+ years of experience) or PhD (with 4+ years of experience) in Statistics, Biostatistics, or a highly related field.
- Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming.
- Knowledge of methodologies for confounding control and bias minimization in observational studies preferred.
- Some experience supporting safety-related projects (eg, ISS, benefit-risk assessment, signal detection) is preferred
- Pharmaceutical or related industry knowledge desired, including experience and understanding of drug development and life-cycle management in the regulated environment.
- 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 manage project timeline and quality of deliverables
Responsibilities
- Support regulatory submission and product life-cycle management strategy planning and implementation.
- Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs.
- Independently develop protocols and statistical analysis plans (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation).
- Lead in identifying scientifically appropriate data collection instruments.
- Independently perform statistical analyses as per the analysis plan.
- Develop strategy for data presentation and inference.
- Lead statistical support for benefit-risk planning and assessment.
Other
- High degree of technical competence and effective communication skills, both oral and written
- 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
- Have strong leadership skills and experience in working/managing cross-cultural or oversea teams
- US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
