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, Global Medical Affairs (GMA) Statistics leads and directs statistical strategies for one or more assigned therapeutic indication areas. A visible and collaborative role, the Director works in partnership with Global Medical Affairs and other key stakeholders to provide scientific and statistical expertise for drug development and life-cycle management strategies; for the design, analysis, and reporting of clinical or other scientific research programs; for generating scientific evidence to support medical affairs strategies; and for interacting with regulatory agencies, medical community and key opinion leaders (KOLs) regarding the results of these activities; evaluates modern program/trial design methodologies with a focus on real world evidence (RWE) gathering, analysis and interpretation.
Major Job Responsibilities
- Direct the development of scientific protocols, ensuring they are scientifically sound, aligned with the product strategy, and meet scientific and/or applicable regulatory needs. Ensure statistical methodology is appropriate and sound, consistent with the objective(s) of the scientific investigations.
- Demonstrate excellent understanding of statistical concepts and methodologies. Take a leadership role in introducing new/novel statistical methodological approaches into analysis plans which improve the efficiency and validity of study results. Be able to explain statistical concepts to non-statistician.
- Review identified or anticipated technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research. Select and supervise the evaluation of alternative analysis strategies or other recommendations to address these issues. Evaluate appropriateness of available software for planned analyses and assess needs for potential program development of novel statistical methodology.
- Maintain technical skills and increase own knowledge of new statistical methodology or areas of application through scientific literature and attendance at professional meetings. Present own statistical research or review of the statistical literature at meetings and seminars. Demonstrates a high degree of responsibility in maintaining Statistics department standards, GxP compliance, and best operating practices.
- In collaboration with GMA, Clinical Statistics, Data Sciences, Statistical Programming and other stakeholders, direct the assessment and evaluation of existing databases, both clinical studies and real-world databases, supervise the conduct of feasibility assessment to identify fit-for-purpose data sources for research questions, and supervise the development of detailed and actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to drive decisions.
- Propose and direct evaluation of alternatives to traditional randomized clinical trials that make use of real-world data bases, e.g. electronic health records, insurance claims databases, and/or registries.
- Represent function/department in cross-functional team(s) and ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with the statistical analyses provided. Ensure timely and quality statistical deliverables. Represent GMA Statistics in addressing questions at management and/or product review meetings. Provide in-depth scientific/statistical review for scientific reports and publications. Ensure the accuracy of the statistical component of scientific reports and/or publications with high quality.
- Lead GMA Statistics group in partnership with GMA, Clinical Research and Clinical Statistics to develop scientifically appropriate strategies for evidence generation, including GMA studies, presentations, and publications in assigned therapeutic area(s). Lead GMA Statistics to provide functional area input for life cycle management of products. Lead communications between assigned product team(s) and functional management. Build/drive cross-functional relationship and collaboration.
- Train and mentor staff on statistical methodology and operations. May supervise contract statisticians. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.
- 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
- Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Knowledge of methodologies for confounding control and bias minimization in observational studies highly desired.
- 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
- Willing to learn new knowledge and technology, open-minded and adapting for improvement, enthusiastic about innovation and a self-starter to make possibilities real.
- 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.
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.