Safety Statistics Senior Manager
2 weeks ago
AbbVie is a leading global biopharmaceutical company dedicated to discovering and delivering innovative medicines and solutions that solve serious health issues. Our mission is to have a remarkable impact on people's lives across several key therapeutic areas, including immunology, oncology, neuroscience, and eye care, as well as our Allergan Aesthetics portfolio.
Job DescriptionWe are seeking an experienced statistician to join our growing Safety Statistics team as a Senior Manager. As a key member of our Product Safety Teams, you will be responsible for leading the development of safety data integration specifications, collaborating with cross-functional teams on benefit-risk planning and assessment, and ensuring the delivery and interpretation of safety outputs.
Key Responsibilities:
- Develop and lead the development of safety data integration specifications in accordance with analysis plans.
- Collaborate with cross-functional teams on benefit-risk planning and assessment, including leading the assessment and development of quantitative benefit-risk methods and data displays.
- Lead the development, delivery, and interpretation of safety outputs, including graphics.
- Collaborate with Statistical Programming to ensure the delivery of high-quality outputs according to agreed-upon timelines.
- Ensure appropriate interpretation of safety deliverables in collaboration with other functions.
- Lead within-SSG efforts and represent SSG in cross-functional efforts to identify and implement strategic initiatives that address processes related to interpreting, monitoring, assessing, and reporting safety data.
Qualifications:
- MS (with at least 8 years of relevant experience) or PhD (with at least 4 years of relevant experience) in Statistics, Biostatistics, or a highly related field.
- Pharmaceutical or related industry experience, including experience and understanding of drug development in the regulated environment.
- Effective oral and written English communication skills.
- High degree of competence in experimental design, descriptive and inferential statistics, and statistical programming.
- Experience interacting with regulatory agencies or with supporting regulatory responses is desirable.
Leadership Competencies:
- Builds strong relationships with peers and cross-functionality with partners outside of the team to enable higher performance.
- Learns fast, grasps the essence, and can change the course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures, and manages innovation to reality.
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