Associate Director/Director, Safety Statistics
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The Director, Safety Statistics provides provides scientific and strategic input and safety statistics leadership for assigned clinical development projects. A visible and collaborative role, the Director works in partnership with patient safety, clinical, and regulatory experts to advance medicines to our patients.
This postion can be remote/virtual
Major Job Responsibilities
- Lead the PST statistical support for one or more clinical development projects through own efforts or those of a team. Lead/develop safety statistical strategy for project development and regulatory submission.
- Direct or provide safety statistical leadership in the safety analysis and reporting for clinical data and ensure appropriate interpretation of safety deliverables in collaboration with other functions.
- Provide strategic input to and oversight of the development of Product Safety Statistical Analysis Plans (PSSAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs) and development of safety data integration specifications in accordance with analysis plan.
- Provide strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory agencies.
- Oversight of the development, delivery and interpretation of safety outputs, including graphics. Oversight of cross-functional development of output specifications to address both pre-planned safety analyses and ad hoc requests. Oversight to ensure the delivery of high-quality outputs according to agreed-upon timelines
- Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects. Build interdepartmental relationships.
- Provide oversight of cross-functional development of output specifications to address pre-planned safety analyses and ad hoc requests. Provide sufficient detail to allow programming implementation and ensure all statistical analyses specified in analysis plans are conducted appropriately.
- Guide development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming and other stakeholders.
- Train and mentor staff on safety statistical methodology and operations. May supervise contract statisticians or junior statisticians. Gain expertise in innovative safety statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.
- Develop safety strategy for data presentation and inference. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
- Ensure that all applicable regulatory requirements for work processes are met, review regulatory submission documents, and represent DSS in discussions with regulatory agencies.
- Lead and provide oversight of contributions by Safety Statistics to benefit-risk planning and assessment, including ensuring delivery and interpretation of benefit-risk data displays/analyses.
- Lead within-SSG initiatives and represent SSG on cross-functional efforts to implement strategic initiatives that address processes related to monitoring, assessing, interpreting, and reporting safety data.
- Identify potential areas to improve processes or statistical methodologies, initiate steps to evaluate possible improvements and develop a plan to implement changes based on this evaluation.
- Stay current with industry trends and practices related to safety and potentially represent SSG/DSS on external initiatives to advance the safety discipline and build external scientific connections which foster professional development and promote the reputation of the Safety Statistics department.
- MS (with 12+ years of experience) or PhD (with 8+ years of experience) in Statistics, Biostatistics, or a highly related field.
- High degree of technical competence and excellent communication skills, both oral and written
- Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others
- Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo
- Have strong leadership skills and experience in working/managing cross-cultural or oversea teams
- Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.
- Demonstrate extensive understanding of statistical concepts and methodology for analysis of safety data.
- Patient safety experts
- Clinical development experts
- Statistical programmers
- Data science experts
- Regulatory experts
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 5 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.