Sr. Manager / Associate Director, Statistics - CMC (Hybrid)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

Purpose:

The Associate Director in CMC Statistics is responsible for providing statistical support across a broad range in nonclinical areas with a focus on Chemistry, Manufacture and Control (CMC), expanding and broadening the application of Biostatistics. He/she is also responsible for helping the group head build the group infrastructure (e.g., developing SOPs) and mentor junior statisticians or interns.

Responsibilities:

• Apply statistical techniques to facilitate better decision-making and improve business operation.
• 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. Participate in establishing 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 st