
Associate Director, Statistics - CMC (Hybrid)
Are you a highly skilled statistician with a passion for drug development and a desire to make a meaningful impact in the pharmaceutical industry? Look no further! AbbVie is seeking an Associate Director of Statistics - CMC (Chemistry, Manufacturing, and Controls) to join our dynamic team. In this hybrid role, you will have the opportunity to lead and provide strategic statistical support for CMC programs across multiple therapeutic areas. We are looking for a motivated and collaborative individual with a strong background in statistics and a desire to drive innovation and excellence in drug development. If you possess strong leadership skills, excellent communication abilities, and a deep understanding of CMC processes, we want to hear from you. Join us at AbbVie and be a part of our mission to improve the lives of patients worldwide.
- Lead and provide strategic statistical support for CMC programs across multiple therapeutic areas.
- Develop and implement statistical strategies for CMC projects, including study design, data analysis, and interpretation.
- Collaborate with cross-functional teams to ensure statistical integrity and timely completion of CMC projects.
- Provide statistical input for regulatory submissions and interactions with regulatory authorities.
- Stay current with industry trends and best practices in CMC statistics.
- Mentor and guide junior statisticians in their professional and technical development.
- Lead and contribute to the development and implementation of innovative statistical methodologies.
- Identify and communicate potential risks and opportunities for CMC programs.
- Collaborate with internal and external stakeholders to ensure alignment and consistency in statistical approaches.
- Represent the company at scientific meetings and conferences, presenting on CMC statistical topics.
- Proactively seek opportunities to drive continuous improvement and excellence in CMC statistics.
- Maintain a high level of accuracy and attention to detail in all statistical analyses and documentation.
- Effectively communicate complex statistical concepts and results to non-technical stakeholders.
- Adhere to all company and industry regulations, standards, and policies related to statistical analysis and reporting.
- Contribute to the overall success of the company by actively participating in strategic planning and decision-making processes.
Advanced Degree In Statistics Or Related Field: A Successful Candidate For The Associate Director, Statistics - Cmc (Hybrid) Position At Abbvie Should Hold An Advanced Degree (E.g. Phd Or Ms) In Statistics, Biostatistics, Or A Related Field.
Experience In Pharmaceutical Or Biotech Industry: Candidates Should Have At Least 8-10 Years Of Experience In The Pharmaceutical Or Biotech Industry, With A Strong Understanding Of Drug Development Processes And Regulatory Requirements.
Strong Statistical Knowledge And Analytical Skills: The Candidate Should Have A Deep Understanding Of Statistical Methods And A Track Record Of Applying Them To Solve Complex Problems In Drug Development.
Experience In Cmc (Chemistry, Manufacturing, And Controls): The Role Requires Experience In Cmc, Which Includes Knowledge Of Manufacturing Processes, Drug Product Development, And Analytical Methods. Candidates Should Have A Strong Understanding Of Regulatory Guidelines And Requirements For Cmc.
Excellent Communication And Leadership Skills: The Associate Director Will Be Responsible For Leading And Managing A Team Of Statisticians, As Well As Collaborating With Cross-Functional Teams. Strong Communication Skills And The Ability To Effectively Lead And Influence Others Are Essential For Success In This Role.
Quality Assurance
Project Management
statistical analysis
Data Visualization
Data Mining
Statistical modeling
Drug development
Statistical programming
Team Leadership
Risk assessment
Regulatory compliance
Statistical Reporting
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Associate Director, Statistics - CMC (Hybrid) in Florham Park, NJ, USA is $115,000 - $150,000 per year. This may vary depending on the specific company, level of experience, and other factors.
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AbbVie is an American publicly traded biopharmaceutical company founded in 2013. It originated as a spin-off of Abbott Laboratories.

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