
Associate Director, Statistics - CMC (Hybrid)
Are you a highly experienced statistician looking for a new challenge? Do you have a passion for leading and developing teams? AbbVie is seeking a driven and dynamic individual to join our team as the Associate Director of Statistics - CMC (Hybrid). In this role, you will have the opportunity to utilize your expertise in statistics and project management to contribute to the success of our company. We are looking for someone who is dedicated, innovative, and a team player. If you have a strong background in statistics and a desire to make a meaningful impact, we invite you to apply for this exciting opportunity.
- Lead and manage a team of statisticians to ensure high quality and timely delivery of statistical support for various projects within the company.
- Develop and implement statistical strategies and methodologies to support drug development and regulatory submissions.
- Collaborate with cross-functional teams including clinical, regulatory, and manufacturing to ensure alignment and successful execution of project objectives.
- Provide statistical expertise and guidance to support decision making and risk assessment for drug development programs.
- Mentor and develop team members, providing guidance and support for their professional growth and development.
- Stay updated on industry trends and advancements in statistical methodologies and tools, and implement best practices within the team.
- Oversee the planning, execution, and reporting of statistical analyses for clinical trials, ensuring adherence to regulatory requirements and company standards.
- Serve as a subject matter expert on statistical issues and contribute to the development and review of regulatory documents, including clinical study protocols, statistical analysis plans, and study reports.
- Collaborate with internal and external stakeholders to identify and resolve statistical issues and provide recommendations for process improvements.
- Support business development by participating in proposal development and client presentations as a statistical expert.
- Ensure compliance with company policies, procedures, and regulatory guidelines related to statistical activities.
- Act as a key liaison with regulatory agencies and participate in regulatory interactions, representing the statistical aspects of projects.
- Foster a collaborative and inclusive team environment, promoting teamwork, open communication, and a positive work culture.
Advanced Degree In Statistics Or Related Field: The Ideal Candidate For This Role Should Possess A Master's Or Phd Degree In Statistics, Biostatistics, Or A Related Field. This Advanced Degree Will Provide The Necessary Technical Foundation For The Statistical Analysis And Interpretation Of Cmc Data.
Extensive Experience In Pharmaceutical Industry: Candidates Should Have At Least 7-10 Years Of Experience In The Pharmaceutical Industry, With A Strong Background In Cmc Statistical Analysis. This Experience Will Demonstrate A Deep Understanding Of The Regulatory Requirements And Processes Involved In Cmc Development.
Leadership Skills: The Associate Director Will Be Responsible For Leading And Managing A Team Of Statisticians, So Strong Leadership Skills Are Essential. The Candidate Should Have A Proven Track Record Of Successfully Leading And Developing Teams To Meet Project Goals And Deadlines.
Knowledge Of Regulatory Guidelines: The Candidate Should Have A Thorough Understanding Of Regulatory Guidelines And Requirements For Cmc Development, Including Ich Guidelines And Fda Regulations. This Knowledge Will Be Critical In Ensuring Compliance And Successful Submissions.
Excellent Communication And Collaboration Skills: As The Associate Director, The Candidate Will Need To Effectively Communicate Complex Statistical Concepts To Both Technical And Non-Technical Stakeholders. Additionally, They Will Need To Collaborate With Cross-Functional Teams, Including Scientists, Engineers, And Regulatory Professionals, To Ensure The Successful Execution Of Cmc Projects.
Quality Assurance
Process Improvement
Communication Skills
Project Management
statistical analysis
Problem Solving
Technical Writing
Data Visualization
Statistical modeling
Team Leadership
Regulatory compliance
Clinical
Communication
Conflict Resolution
Leadership
Time management
creativity
Organization
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Associate Director, Statistics - CMC (Hybrid) in Worcester, MA, USA is between $120,000 to $150,000 per year, depending on experience and qualifications. This may vary based on the specific company and industry that the individual is working in. Some companies may offer higher salaries for positions with more responsibilities and experience, while others may offer lower salaries for entry-level positions. Additionally, factors such as education level, certifications, and job performance can also affect an individual's salary as an Associate Director, Statistics - CMC (Hybrid).
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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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