Associate Director, Statistics - Immunology
Listed on 2025-12-18
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Healthcare
Healthcare Management, Healthcare Administration
Associate Director, Statistics - Immunology – Bio Space
Abb Vie is a global biopharmaceutical company dedicated to discovering and delivering transformative medicines. The “Associate Director, Statistics - Immunology” role offers statistical leadership in clinical development and life‑cycle management across assigned projects, including clinical trials, patient safety, and global medical affairs.
Location & Work ArrangementThis role is based at Abb Vie locations in Lake County, IL or Florham Park, NJ, and will operate on a hybrid schedule.
Job DescriptionThe Associate Director provides statistical strategy, design, analysis, reporting, and regulatory oversight for clinical and scientific research programs. Responsibilities also include mentoring staff, liaising with CROs and external collaborators, and ensuring compliance with all regulatory and SOP requirements.
Responsibilities- Provide statistical support for one or more clinical development projects through independent or team effort.
- Lead and develop statistical strategy for project development and regulatory submission.
- Define protocols and statistical analysis plans; oversee design, analysis and reporting of clinical or other scientific research programs.
- Represent the Statistics function on project teams and collaborate with Clinical, Regulatory, Patient Safety, and GMA to develop integrated strategies.
- Employ advanced statistical concepts and propose methodological innovations for study design, ensuring deliverables are statistically sound.
- Train and mentor staff; supervise contract or junior statisticians as necessary.
- Develop strategies for data presentation and inference, ensuring accurate interpretation of statistical deliverables.
- Serve as liaison for statistical issues in Abb Vie collaborative studies with CROs, academic institutions, government agencies, committees, joint ventures, and licensing partners.
- Ensure regulatory compliance, critically review submission documents,
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