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Associate Director, Biostatistics
1 month ago
The Associate Director in CMC Statistics is responsible for providing statistical expertise across a broad range of nonclinical areas, with a focus on Chemistry, Manufacture and Control (CMC). This role involves expanding and broadening the application of biostatistics to drive better decision-making and improve business operations.
Responsibilities:- Apply statistical techniques to facilitate better decision-making and improve business operations.
- Regularly interact with management of different levels in strategy meetings.
- Contribute to strategic planning to ensure statistically optimized non-clinical development plans and assist in the creation of strategic objectives for regulatory filings.
- Participate in the planning/design, conduct, analysis, and interpretation of CMC studies and regulatory submissions.
- Establish departmental and nonclinical SOPs and guidelines.
- Develop statistical tools to streamline process development, QC testing, and troubleshooting.
- Collaborate with colleagues from other departments to ensure compliance with regulations and help implement regulatory initiatives such as Quality by Design and process validation.
- Collaborate with external colleagues on consortia and other research projects relevant to nonclinical topics.
- Prepare statistical courses and provide training to scientists.
- Mentor junior staff, proactively help with both their technical and career development, and seek general feedback and technical input from colleagues.
- Develop and deliver statistical and scientific publications and present internally and externally.
- Collaborate with other statisticians in improving and sharing statistical approaches.
- Maintain and expand expertise in various computing tools to leverage internal and external data sets to drive decisions.
This position requires a strong background in statistics, biostatistics, or a highly related field. The ideal candidate will have a high degree of technical competence and excellent communication skills, both oral and written. Experience in leading safety-related projects and competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming are highly desirable.
Additional Information:AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. We offer a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
