Scientist, Biostatistics

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.

Responsibilities:

• Develops, coordinates, and provides biostatistical support for drug/vaccine projects under supervision in Late Development Statistics.   

• Interacts with Clinical, Regulatory, Statistical Programming, Data Management and other Scientists in analyzing clinical trials, and in coordinating other statistical activities for clinical drug/vaccine projects under supervision.

Primary activities:

• Under the guidance of senior statisticians, serves as the statistical representative on cross-functional teams engaged in the planning, execution, analysis and reporting of a clinical trial.

• Under the guidance of senior statisticians, participates in study design and preparation of statistical analysis plans, including selecting appropriate designs to address relevant clinical questions, computing sample sizes and conducting simulations to evaluate the properties of study designs, as needed, and selecting appropriate statistical methods for analyzing the data.

• Participates in database design meetings and reviews relevant study documents to ensure that the study data are of high quality and satisfy analysis requirements and monitors data in an ongoing fashion during the study to ensure data quality and verify that the data satisfy the assumptions for the planned analyses.

• Collaborates with the statistical programming staff to define, document, and review derived variables needed for planned analysis and ensures that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.

• Analyzes data and interprets results from clinical trials. Reviews study results to ensure all deliverables are of high quality.

• Under the guidance of senior statisticians, prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators.

• May assist with departmental initiatives and research activities for innovative statistical methods and applications in clinical trial development.

Education and Minimum Requirement:

• A minimum of a Master’s degree or equivalent in statistics/biostatistics or related discipline is required

Required Skills and Experience:

• Knowledge of statistical analysis methodologies and experimental design. 

• Familiar with statistical and data processing software e.g. SAS and/or R. 

• Good oral and written communication skills. Able to work effectively with personnel with different functional backgrounds.

• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus …