Associate Director - Statistics, Specialty TA (Hybrid)
About The Position
The Associate Director, Statistics provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. The role may cover clinical trials, patient safety, and global medical affairs, and partners with experts across multiple disciplines to advance medicines to patients. The position leads statistical strategy and work for regulatory submissions and product life-cycle management, including study design, analysis, reporting, protocols, and statistical analysis plans. It represents the Statistics function on project teams and collaborates with Clinical, Regulatory, Patient Safety, and Global Medical Affairs partners. The role also supports staff development, external scientific collaborations, regulatory compliance, and the interpretation and communication of research findings. The position is hybrid. The posted annual base salary range is USD 141,500 to USD 268,500. AbbVie offers paid time off, medical, dental, and vision insurance, and a 401(k) to eligible employees. The role is eligible to participate in long-term incentive programs.
Requirements
- MS in Statistics, Biostatistics, or a highly related field with 10 or more years of experience, or PhD in one of these fields with 6 or more years of experience.
- Strong leadership skills and experience working with or managing cross-cultural or overseas teams.
- Pharmaceutical or related industry knowledge, including experience and understanding of drug development and life-cycle management in a regulated environment.
- High degree of technical competence and excellent oral and written communication skills.
- Ability to identify data or analytical issues and help provide solutions using personal expertise or seeking assistance from others.
- Ability to manage project timelines and the quality of deliverables.
- Ability to build strong relationships with peers and cross-functional partners to achieve higher performance.
- Motivation to drive innovation by raising standards and challenging the status quo.
Nice To Haves
- PhD preferred.
- Submission experience preferred.
Responsibilities
- Lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects.
- Provide statistical leadership for the design, analysis, and reporting of clinical or other scientific research programs.
- Independently develop study protocols and statistical analysis plans.
- Represent the Statistics function on project teams, provide statistical input to compound or drug development, and drive alignment with functional management.
- Partner with Clinical, Regulatory, Patient Safety, and Global Medical Affairs functions to create development strategies for assigned projects.
- Propose statistical methodology for scientific study design and provide sufficient detail for programming implementation.
- Ensure statistical analyses specified in scientific protocols and analysis plans are conducted appropriately.
- Train and mentor staff on statistical methodology and operations; may supervise contract or junior statisticians.
- Assist functional leaders with recruiting qualified personnel and arranging professional development training.
- Develop strategies for data presentation and inference, and ensure appropriate interpretation of statistical deliverables with other functions.
- Collaborate on scientific publications and ensure the accuracy and internal consistency of reports and publications, including tables, listings, and figures.
- Serve as liaison on statistical issues for collaborative studies with CROs, academic institutions, government agencies, committees, joint ventures, and licensing collaborators.
- Build external scientific connections that foster professional development and promote the Statistics department.
- Ensure applicable regulatory requirements for work processes are met, critically review regulatory submission documents, and participate in regulatory agency discussions as needed.
- Validate external statistical software for compliance with SOPs and regulatory requirements.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Director
