Senior Scientist, Biostatistics, Early Development Statistics

Job Description

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.

This position is for a statistician who will contribute to early development clinical trials aimed at identifying, developing and validating biomarkers and platforms that can be used to make early go/no go decisions for our company's compounds. This would include working directly and partnering with cross-functional discovery/development teams.

Responsibilities:

·       Provides biostatistical support for drug/vaccine projects in Early Clinical Development Statistics.

·       Ensures that sound scientific principles and statistical methods are applied to designing and analyzing clinical studies in support of discovery/experimental medicine/clinical pharmacology clinical trials (and possibly worldwide regulatory submissions).

·       Interacts with Clinical, Regulatory, Statistical Programming, Data Management and our company's Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.

·       Conducts project work and applied research, as needed.

Primary activities:

·       Serves as statistical representative on cross-functional teams for the strategic planning and execution for product discovery and development.

·       Develops individual protocols and data analysis plans and determines appropriate statistical methodology for data analysis.

·       Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.

·       Collaborates with the statistical programming staff, as needed, to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.

·       Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.

·       Prepares oral and written reports to effectively communicate results of clinical studies to the project team, management, regulatory agencies, or individual investigators.

·       Provides responses to queries relating to study design, analysis and interpretation posed by the scientists, clinical monitors, regulatory agencies and/or other investigators.

·       Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.

·       Participates in research activities for innovative statistical methods and applications in clinical trials for drug development.

Education Minimum Requirement:

·       PhD or equivalent degree in statistics/biostatistics, or (ii) a Master's degree in statistics/biostatistics with a minimum of 3 years relevant experience.

Required Experience and Skills:

·       Solid knowledge of statistical analysis methodologies and experimental design.

·       Solid knowledge of statistical and data processing software e.g. SAS and/or R. Strong oral and written communication skills. Able to function effectively in a team environm