• Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful program support. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives.
• Applies high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability.
• Complies with organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understands and aligns with relevant regulatory guidance’s.
• Builds cross-functional partnerships with internal colleagues and with external partners (e.g. Contract Research Organizations (CROs), consultants) to achieve results for project specific needs with focus on improving communication, efficiency, and productivity.
• Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical trial team, and the Statistics Area Head.
• Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards. Follows best practices for Data Integrity.
• Demonstrates thorough knowledge of pharmaceutical research and development strategies and execution. Takes a lead in providing SDS support to experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications.
• Accountable for execution of individual project responsibilities, including: meetings with necessary project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications for individual clinical trials/studies/projects.
• Evolving leader for providing input to team in terms of optimizing study or trial designs in line with study or indication level objectives, and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional area knowledge.
• Demonstrates knowledge for at least one disease area/target.
• Suggests and performs the evaluation of alternative or innovative approaches to statistical methods or business processes.
• Represents Statistics & Decision Sciences for cross-functional and intra-departmental teams or working groups relating to scientific or process initiatives.
• Participates as a member of professional organizations, e.g. by attending meetings as chair or presenter.
• Supervises contractors/special assignment personnel/interns/co-ops as required. Mentors junior colleagues in techniques, processes, and responsibilities.
• Participates in process improvement or standards development initiatives.
• A Ph.D. in Biostatistics or Statistics with a minimum of 2 years post-doctorate experience is required.
• Proficiency in R or SAS, as well as a working knowledge of other relevant computational tools is strongly required.
• Ability to work in a matrix organization and cross-functionally to identify and resolve issues is preferred.
• Demonstrated ability to collaborate and consult with non-statisticians, translating complex statistical concepts to drug research & development partners is required.
• Bridges scientific and business needs – integrating quantitative sciences and strong disease or functional area knowledge and appropriate market/competitive intelligence is strongly preferred.
• Knowledge of biostatistics applied to clinical trials is required.
• Some experience with planning, running, and documenting simulations (including, but not limited to clinical trial simulations) is preferred.
• Very good written, oral, and interpersonal communication skills is required.
Requisition ID: 0401180121