Associate Director, Global Medical Affairs 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.
Associate Director, DSS Global Medical Affairs (GMA) Statistics
Global Medical Affairs (GMA) Statistics is responsible for partnering with AbbVie GMA and other corporate functions to provide expertise in biostatistics and mathematics. The partnership is realized in the context of a cross-functional, product-oriented effort to provide statistical expertise and consultation for all key GMA business activities, including but are not limited to GMA research proposal reviews, strategic planning and input on TA strategies, real world evidence (RWE) study designs, real world database (RWD) research, scientific presentations and publications for all therapeutic areas, vendor oversight of study executions, RWE methodology research, and evidence evaluations and generations.
- Provide scientific and statistical expertise through own efforts and those of her/his staff (if appropriate) for drug development and life-cycle management strategies for assigned projects; for the design, analysis, and reporting of clinical and 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.
GMA Study Protocol Development:
- 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. Independently select, evaluate and implement 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 to evaluate existing databases, both clinical studies and real-world databases, conduct feasibility assessment to identify fit-for-purpose data sources for research questions, and develop detailed and actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to drive decisions.
- Evaluate 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.
Scientific Reports and Publications:
- Play a key role in the cross-functional team 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. Assist other GMA Statistics colleagues or 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.
Consultation and External Engagement:
- Partner with multiple stakeholders to develop scientifically rigorous development strategies for one or more major drug discovery or development projects
- Works with manager and administrative staff to arrange for and manage alternative resources (i.e., consultants, CROs, interns, temporary staff) to meet project priorities.
- Interact with relevant stakeholders to ensure that appropriate statistical methods are adequately and consistently applied in all scientific and regulatory documents, presentations, and publications.
- Provide scientific/statistical insight in addressing questions from internal and external stakeholders, and proposes novel solutions to technical issues.
- Independently pursue analyses suggested by the data, including the pursuit of statistical knowledge needed to address the scientific issue.
- In collaboration with Statistical Programming or their designee, ensures that all internal and external statistical software used for the analyses defined in SAPs or scientific research plans are efficient, validated, and meet internal SOPs and external regulatory requirements.
- Act as the liaison for statistical issues on AbbVie collaborative studies with academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing activities.
- Build external scientific connections which foster professional development and promote the reputation of the Statistics department.
- Demonstrate broad understanding of scientific research designs, worldwide regulatory requirements and commercial aspects of drug development and life-cycle management.
- Critically review regulatory and/or reimbursement agency submission documents for one or more major drug development or life-cycle management projects.
- Effectively and persuasively present statistical concepts, evidence, interpretations, and logical arguments to the project team, management, regulatory agencies, and scientists.
Product Team Involvement:
- Support or 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). Support or lead GMA Statistics to provide functional area input for life cycle management of products. Support or lead communications between assigned product team(s) and functional management. Build/drive cross-functional relationship and collaboration
Position will be hired based on level of experience. Location can be either North Chicago, IL or Madison, NJ
For Associate Director:
- MS (with at least 10 years of experience) or PhD (with at least 6 years of experience) in Statistics, Biostatistics, or a highly related field.
- High degree of technical competence and sound 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 provide 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 managing a programming group. Experience in working/managing cross-cultural or oversea teams.
- Pharmaceutical or related industry experience required, including experience and understanding of drug development and life-cycle management in the regulated environment
- Learns fast, grasps the 'essence' and can change the course quickly where indicated
- AbbVie is an Equal Employment Opportunity employer: 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.
- Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
- Travel: 5%
- Job Type: Experienced
- Schedule: Full-time
Significant Work Activities
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.