Associate Principal Scientist, Biostatistics Full-time NEW

Biostatistics And Research Decision Sciences Quantitative Scientist

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 leadership and support for related drug/vaccine projects in Late Development Statistics.
• Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and other Research & Development Division Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects. May interact with Contract Research Organization (CRO).
• This position may serve as a statistical lead in project teams.
• The incumbent may initially work in a specific disease area.

Primary Activities:

• Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development
• Is involved in 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.
• 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 statistical techniques to these analyses.
• Prepares oral and written reports to effectively communicate results of clinical trials to the project team, our Company's 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.
• Mentors and guides junior staff in functional activities.

Education and Minimum Requirement:

PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years relevant work experience, or a Master's degree with a minimum of 6 years relevant work experience.

Required Skills and Experience:

• Solid knowledge of statistical analysis methodologies and experimental design.
• Working knowledge of statistical and data processing software e.g. SAS and/or R.
• Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
• Strong oral and written communication skills. Able to function effectively in a team environment.
• 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:

• Publications in peer reviewed statistical/medical journals.
• Solid project management skills. An understanding of biology of disease and drug discovery and development.