Assistant Director, Global Medical Affairs Statistics
Global Medical Affairs (GMA) Statistics is responsible for providing services in the area of biostatistics and mathematics to Global Medical Affairs and other corporate divisions. These services are supplied in the context of a cooperative, product-oriented effort and included supporting all GMA studies, scientific presentations and publications for all therapeutic areas, evidence evaluations and generations based on real world evidence, and Health Technology Assessment.
Key Responsibilities Includes:
Key Responsibilities Includes:
- Directs the development of scientific protocols, ensuring they are scientifically sound and the research hypotheses and corresponding study designs are aligned with the product strategy, and meet scientific and/or applicable regulatory needs. Ensures statistical methodology is appropriate and sound, consistent with the objective(s) of the scientific explorations
- Demonstrates outstanding understanding of statistical concepts and methodologies. Takes a leadership role in introducing new/novel statistical methodological approaches into analysis plans which improve the efficiency and sensitivity of study results. Provides sufficient details to allow programming implementation. Ensures that all the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately
- In collaboration with GMA, Clinical Statistics, Data Sciences, Statistical Programming and other stakeholders to assess and evaluate existing databases and real world evidence for evidence evaluation and generation to deliver useful, customer-centric evidence and insights to drive decisions
- Ensures that study results and conclusions are scientifically sound, clearly presented, and supported by the statistical analyses provided. Ensure timely and quality statistical deliverables. Represents DSS GMA Statistics on product issues at management and/or product review meetings. Provides in-depth scientific/statistical review for scientific reports and publications. Ensures the accuracy of the statistical component of scientific reports and/or publications with high quality
- Reviews identified or anticipated technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research. Approves and implements alternative analysis strategies or other recommendations to address these issues. Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
- Works collaboratively with members of multi-function teams to complete project deliverables per agreed timelines. Keeps management informed on important scientific/statistical issues that may arise, in a timely manner. Provides responses to routine and non-routine questions from clients, and independently pursues analyses suggested by the data.
- Maintains technical skills and increases own knowledge of new statistical methodology or areas of application through use of the scientific literature and attendance at professional meetings. Presents 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.
- M.S./Ph.D. in Statistics, Biostatistics or a related field. At least 6-8 yrs (PhD) or 10-12 yrs (MS) experience in pharmaceutical development and applied statistics/statistical consulting. Project lead experience required. Broad knowledge of statistical methodology and global regulatory requirements, expertise in drug discovery or development, and an understanding of commercial aspects of drug development.
- Advanced knowledge of statistical methodology and global regulatory requirements, expertise in drug discovery or development, and an understanding of commercial aspects of drug development
- Must have demonstrated exemplary statistical experience in managing and completing multiple projects or equivalent experience
- Experience interacting with regulatory agencies highly desirable
- Excellent communication skills, both oral and written