Director, Statistics

Job Description
The Director, Medical Affairs &
Health Technology Assessment (MA&
HTA) 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 Medical Affairs, Market Access &
Pricing 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 and reimbursement strategies;
and for interacting with health technology assessment (HTA) bodies, 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 health authority 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 Medical Affairs, Clinical Statistics, Data Sciences, Statistical Programming, Market Access 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 and scientific publications.
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, to fill critical evidence gaps.
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 MA&
HTA Statistics in addressing questions at management and/or product review meetings. Provide in-depth scientific/statistical review for study protocol, scientific reports and publications. Ensure the accuracy of the statistical component of scientific reports and/or publications with high quality.
Lead MA&
HTA Statistics group in partnership with Medical Affairs, Clinical Research, Market Access and Clinical Statistics to develop scientifically appropriate strategies for evidence generation, including real-world studies, presentations, and publications in assigned therapeutic area(s). Lead MA&
HTA 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 junior statisticians. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.