Senior Manager, Statistics
Senior Manager, Statistics
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Job Description
1. Position Summary
We are seeking a highly motivated and technically strong statistician to join our Data & Statistical Sciences (DSS) team in China as Senior this role you will provide strategic statistical leadership and support for clinical trials conducted both in China and globally including planning analysis and engagement with China regulatory authorities. This position is ideal for individuals with a solid technical foundation who are ready to independently lead the statistical strategy of clinical development projects and make impactful contributions to healthcare innovation. You will collaborate with cross-functional teams to proactively shape project direction and provide expert statistical guidance throughout the drug development process.
2. Major Job Responsibilities
- Lead the statistical support for one or more clinical development projects through own eorts or those of a team. Lead/develop statistical strategy for project development and regulatory submission.
- Provide statistical leadership in the design analysis and reporting of clinical or other scientific research programs. Support protocol development and lead both statistical analysis plans and statistical programming plans.
- Provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions to co-create development strategies for assigned projects.
- Demonstrate understanding of statistical concepts and methodology. Provide sucient details to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately.
- Guide development and implementation of project-specific database-related activities in collaboration with Data Sciences Statistical Programming and other stakeholders.
- Supervise contract statisticians or junior statisticians. Gain expertise in innovative statistical methods. Assist functional leaders in arranging training opportunities for professional development of sta.
- Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications including tables listings and figures.
- Act as the liaison for statistical issues on AbbVie collaborative studies with CROs academic institutions government agencies steering and/or data monitoring committees joint ventures or licensing activities
- Collaborate effectively with both Global and China-based teams acting as a communication bridge to align statistical deliverables and ensure mutual understanding of clinical and regulatory expectations.
- Lead the development and critical review of statistical deliverables for China regulatory submissions including overseeing the preparation of statistical review documentation addressing regulatory queries and ensuring compliance with evolving local regulatory requirements.
- Explore and apply AI-powered tools to solve business problems increase productivity and improve effectiveness.
Qualifications :
- MS (with 8 years of experience) or PhD (with 4 years of experience) or higher in Statistics Biostatistics Applied Mathematics or a related field
- Familiarity with at least one statistical programming language (e.g. SAS R Python)
- Able to perform statistical computations and simulations
- Able to identify data or analytical issues and assist with providing solutions by either applying own skills and knowledge or seeking help from others
- Highly motivated to drive innovation by raising the bar and challenging the status quo
- Pharmaceutical or related industry knowledge desired including experience and understanding of drug development and life-cycle management in the regulated environment.
- High degree of technical competence and excellent written and verbal communication skills in both Mandarin and English.
- A proactive learner with strong attention to detail and the ability to work in a team-based environment
4. Preferred Qualifications
Exposure to AI-based tools or programming libraries
5. Key Stakeholder:
- Clinical development experts
- Statistical programmers
- Data science experts
- Regulatory affair experts
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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No
Employment Type :
Full-time
Employment Type
Full-time
