In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.
Requirements
- Solid knowledge of statistical analysis methodologies and experimental design.
- Strong scientific leadership in design and analysis of clinical trials
- Solid knowledge of statistical and data processing software e.g. SAS and/or R.
- Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
- Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development.
- Publications in peer reviewed statistical/medical journals.
- Biostatistics, Clinical Development, Clinical Trial Management Processes, Clinical Trials, Clinical Trials Analysis, Data Analysis, Data Management, Data Science, Numerical Analysis, Scientific Modeling, Statistical Analysis, Statistical Programming, Statistics
Responsibilities
- Lead, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Late Development Statistics.
- Lead the interaction with Clinical, Regulatory, Statistical Programming, Data Management, and other Scientists from our Research & Division in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
- Lead biostatistics in early or late clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
- Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out.
- Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis.
- May lead a team of statisticians and statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements
- Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
Other
- Serves as a statistical lead in project teams.
- Interacts with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.
- The incumbent may initially work in a specific disease area.
- Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development
- Lead a team of statistical and/or programing staff assigned to a development project as needed
