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Manager, Medical Affairs & Health Technology Assessment Statistics
Madison, New JerseyAnzeigen-ID 2210506Kategorie Research and DevelopmentBereich AbbVie
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. In addition, this role may also support Health Technology Assessment (HTA) supporting market access and reimbursement.
Provide statistical expertise for design, analysis and reporting of clinical or scientific research studies or programs and contribute to development of modern program/trial design methodologies with a focus on real world evidence (RWE) gathering, analysis and interpretation. Compliant with applicable corporate and divisional policies, procedures and cultural values.
Assist or 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 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. Demonstrate 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 to address research questions, and develop detailed and actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to drive decisions.
Ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with statistical analyses provided. Ensure timely and quality statistical deliverables. Assist with 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.
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
MS (with at least 6 years of experience) or PhD (with at least 2 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 preferred.
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 knowledge preferred, 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)
Job Type: Experienced
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)