Responsibilities
Develops, coordinates, and provides biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics.
Interacts with Clinical, Regulatory, Statistical Programming, Data Management and other Scientists part of our Research & Development Division in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
The incumbent may initially work in a specific disease therapeutic area.
Primary activities
- Serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.
- 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 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.
- Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex techniques to these analyses.
- Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators.
- Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
- Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
- Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
- Involved in research activities for innovative statistical methods and applications in clinical trial development
Education and Minimum Requirement:
PhD or equivalent degree in statistics/biostatistics or related discipline, or a Master’s degree with a minimum of 3 years relevant experience.
Required Skills and Experience:
- Knowledge of statistical analysis methodologies and experimental design.
- Working knowledge of 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 background.
- Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
- Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.
Preferred Skills and Experience:
- An understanding of biology of disease and drug discovery and development.
